chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID test positive; COVID test positive; COVID test positive; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team and product quality group, Program ID.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3249), on 11Feb2021 as dose 2, single (Lot number: EM9810), on 30Aug2021 as dose 3 (booster), single (Lot number: EW0186) and on 02Aug2022 as dose 4 (booster), single (Lot number: FP7138) at the age of 78 years, in right deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Aug2022, outcome "unknown" and all described as "COVID test positive"; DISEASE RECURRENCE (medically significant) with onset 01Oct2022, outcome "unknown", described as "COVID test positive". The event "covid test positive" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (24Aug2022) Positive; (01Oct2022) Positive; (unspecified date) Negative. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Therapeutic measures were taken as a result of disease recurrence.  Clinical course: Clarified that they had to get another booster because they were going on a cruise and flew to visit family. Husband got sick first and tested positive on 24Aug2022. Apparently, the dose they got on 02Aug2022 was the Monovariant. Thinking, probably they had the Omicron variant when they were in withheld. Since patient got sick after he had the second booster, should he now get the Bivariant booster. No treatment was given, cousin was physician, they did not give out Paxlovid. Test results: Yes, when they came back from vacation in Sep2022, patient tested positive for COVID again, 01Oct2022 and was then put on Paxlovid. No prior vaccinations within 4 weeks. No family medical history relevant to adverse events. Was feeling terrible, did home test that was negative, was really feeling lousy. Went to local, free-standing ER, they did another COVID test that was positive and he was prescribed the Paxlovid. Clarified he was not admitted to hospital.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events  vaccination failure/ COVID 19  disease recurrence and the suspect drug BNT162B2 cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300038437 same reporter/drug/event, different patient;
Initial Health Authority report received on 11 Jan 2010: This patient had vaccination history of FLUVIRIN with adverse events fever, headache, dizziness, muscle aches and inability to concentrate or focus on an unspecified date (case: PHHY2010US49621). This patient had received Hepatitis, Tetanus and Tuberculosis immunizations in Aug 2009. She had allergy to penicillin, CODEINE and shell fish. The patient received H1N1 (batch number unknown), on 02 Dec 2009. She experienced sweat profusely and the injection site became sore with muscle pain and burning. She began to loose ability to concentrate and focus on 02 Dec 2009. The patient also got a migraine type headache with blurred vision. The patient visited emergency room. She was treated with BENADRYL, 25 mg, 2 capsules, and every 4 hours orally until on visit on 03 Dec 2009. After medical examination, the patient received MEDROL dose pack (6 days decreasing) from on an unspecified date and still ongoing. The seriousness criterion reported as life threatening. The outcomes of events were reported as unknown.
7 Days after shot, injection site started to swell. There is soreness, redness, and itchiness.
erythema on upper forearm; urticaria lesions around site of injection; This case was reported by a physician via call center representative and described the occurrence of erythema of extremities in a child patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) (batch number 2SM24, expiry date unknown) for prophylaxis.   On 30th September 2020, the patient received FluLaval Tetra 2020-2021 season. On 1st October 2020, 1 days after receiving FluLaval Tetra 2020-2021 season, the patient experienced erythema of extremities and injection site urticaria. On an unknown date, the outcome of the erythema of extremities and injection site urticaria were unknown.   It was unknown if the reporter considered the erythema of extremities and injection site urticaria to be related to FluLaval Tetra 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a later response. The patient experienced local erythema on upper forearm and urticaria lesions around site of injection. The reporter consented to follow up. The reporter found suspicious that same lot number was involved in many adverse event in the clinic. The reporter could not find expiration date from this Flulaval shot.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202326:same reporter US-GLAXOSMITHKLINE-US2020202330:same reporter US-GLAXOSMITHKLINE-US2020204774:same reporter US-GLAXOSMITHKLINE-US2020204778:same reporter
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. On 2nd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 3rd April 2018, 1 days after receiving SHINGRIX, the patient experienced influenza-like symptoms. The patient was treated with paracetamol (Tylenol). On 4th April 2018, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: They symptoms lasted 24 hours then resolved.
Presented to employee health services on 11/18/11 with raised erythematous maculopapular area 25 x 40 mm on right arm. Indurated, painful & warm w/central puncture mark. BENADRYL 25 mg tabs given w/directions to take tid-qid prn.
received vaccine at 3pm /Developed swelling of mouth, eyes and difficulty breathing at 4:30pm.Did not seek medical attention until next morning at which time he went to ER. Given IV prednisone and sent home with script for oral prednisone.
Immediately felt flush, mediciney taste and smellin back of throat and nasal. Taste and smell continued for 3 days. About hour after shot had pressure in middle of chest and top of abdomen. Painful to take deep breath. Pressure would build and then would have to burp, which would be painful. Also shortness of breath. This was constant and lasted about 8 days. Would wake me at night.
Swelling inside collar bone area on side of injection. Possibly lymph node. First time noticing swelling is approximately 7 days after 1st injection.  Over the next 3 weeks, swelling decreased to almost normal until 2nd dose.  After that, swelling was noticed approximately 48 hours later and correlated vaccine with swelling. Between the 1st and 2nd dose, I visited MD, Physical Therapists, Massage therapist.  Other symptoms included popping of collar bone when shrugging shoulder.
headache; muscle pain; joint pain; fatigue; blister/pocket of infection developed on thumb; feels like electric shock in fingers and hand; Swelling in the left hand/Left thumb swelling; Thumb is fire red; pain in hand/thumb; numbness in fingers; can't bend fingers; A spontaneous report was received from a consumer concerning about a 71 years old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feels like electric shock in fingers and hand (electric shock sensation), swelling in the left hand/left thumb swelling (peripheral swelling), thumb is fire red (erythema), pain in hand/thumb (pain in extremity), numbness in fingers (hypoaesthesia), can't bend fingers (musculoskeletal stiffness), blister/pocket of infection developed on thumb (infection localized), headache, muscle pain (myalgia) and joint pain (arthralgia).  The patient's medical history was not reported.  Concomitant medications included pain medications, acid reflux medication, blood pressure medication, and aspirin.    On 05 Feb 2021, prior to the onset of the events, the patient received their first planned doses of mRNA-1273 (Batch number: 013M20A) intramuscularly in left arm for the prophylaxis of COVID-19 infection.  On 10 Feb 2021, five days following the first vaccination, the patient experienced swelling in the left hand, left thumb swelling, thumb is fire red, swelling, painful, numbness in fingers, feels like electric shock in fingers and hand and cannot bend fingers. On 16 Feb 2021, patient saw physician and received antibiotics for seven day treatment due to a blister/pocket of infection that developed on thumb. Patient's hand and thumb remained serious at the time of the report and the pinky finger was twice the usual size. The patient reported generalized headache (on and off), muscle pain, joint pain, and fatigue.   Treatment information included unspecified antibiotics.  There was no change planned to the dosing schedule of mRNA-1273 in response to the events.  The outcomes of all the events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
She developed a papular rash, 2 days post vax, plus cough, rhinorrhea and mild fever. Rash was still present on 4/26/2000 but not vesicular yet.
Arm soreness for a couple days  Joint pain in knees and arms for 3 weeks
It hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comment: This case was reported by patient via interactive digital media. The patient received a dose of Shingles vaccine (actually 2 shots) this year and it hurt. Additional supportive information: The follow-up would not possible, as no contact, details were available. The case US2022AMR140129 was created in error was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
Initial report was received on 07 July 2011 from a consumer who is also the patient's parent. A 15 year-old female patient with no reported past medical history had received an intramuscular injection of MENACTRA (lot number and site of administration not reported) on 05 July 2011 and the next morning woke up with a backache, stiff neck, fever and vomiting. According to the reporter, the patient's "problems" were getting worse. The patient was not evaluated by a physician. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was not recovered. Follow-up information was received on 14 September 2011 from a health care professional. On 05 July 2011, the patient had received an intramuscular right deltoid injection of MENACTRA, lot number U4001AA, a dose one left deltoid injection of ADACEL, lot number C3921BA (route of administration not reported) and a second dose right arm deltoid injection of VARIVAX, Merck lot number 0095AA (route of administration not reported). The patient had no illness at the time of vaccination, no concomitant medications and had no history of adverse events following prior vaccinations. The patient had a primary series of Tdap with the "last one 7/19/0" (entire year not reported). The reporter had no additional information to provide at the time of the report. The patient's outcome was recovered (date not reported). Follow-up information was received from a health care professional on 03 November 2011. The patient had been given the fifth dose of Dtap (also reported as Tdap) on 19 July 2000 (previously reported as "0"). The patient had received ADACEL IM (intramuscularly) and VARIVAX SC (subcutaneously). No further information was available at the time of the report. Outcome was recovered. Documents held by sender: none.
pt recv vax 13JUL95 & 2 days p/vax pt devel a local rxn @ site of vax described as inflamed, hot, hard  & painful;pt did not devel a fever;MD suspected cellulitis & pt was started on med;no hx of prev pneumococcal immun or pneumococca
Fatigue, anhedonia, decreased libido, depression begining December 2002 after completing initial series of anthrax vaccine.  Symptoms to today - has documented hypogonadism on treatment.
Moderna COVID-19 Vaccine EUA Itching,  hard red area the size of a soft ball.  Continues  today.  Warm  compress.
Systemic: Anaphylaxis-Medium, Systemic: Fainting-Medium
At first chills, fever (flu-like symptoms), lasting 3-4 days. Then pain up legs, numbness in feet and up legs. Pain was excruciating up legs. Then on Saurday, 9/1/18 went to the ER. The symptoms slowly went up legs. After several trips to the ER and admission to Medical Center, was diagnosed with GBS (Guillain-Barre Syndrome).
Woke up in severe pain in heart, back, neck, shoulders, jaw, lungs - very difficult and painful to breathe.  Went to ER several hours later.
Deltoid injection, given high on deltoid.  Immediate pain and swelling.  Did not resolve with time.  Pain and weakness persists.
Red disc-shaped rash (approximately 3 in diameter) appeared about 24 hours after vaccine administration. Rash was very itchy. Patient consulted with PCP and has started BENADRYL 25mg every 4-6 hours until resolved.
24hr later felt sick, slept 14hr 2 noc in a row;painful, hard lump that lasted about 1wk;skin around lump red & hot, blotchy almost looked infected-lt arm affected;
onset of "throat swelling";  went to urgent care ; he denied any hives, itching, SOB , wheeze or lightheadedness; On evaluation at  2:00pm,  BP 144/102;   P96;  Po2 98%;   Exam indicates no abnormals- no swelling noted; Treated with  80 mg Kenalog IM and 50 mg Benadryl po and discharged stable  - no Rx I evaluated him on 12/22 - no further symptoms since urgent care;  vital signs stable;
Onset of dizziness, sweating, heart racing, body aches, fever to 102.3
Tingling all over body, headache, drowsiness, dizziness, fainting, nausea, vomiting, redness and swelling of face, strained breathing/shortness of breath.
patients were given shots during excursions.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions.) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions.). On 28-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   This case was linked to MOD-2021-423403 (Patient Link).
"Patient recently immunized with adult dose COVID booster on 3/8 and developed fever and chest 1 day after receiving vaccine. His T max was 101 over the past 48 hours. This AM, around 0300, patient woke with chest pain and feeling like something was stuck in his throat. He felt he could breathe normally (though ED note notes some difficulty with breathing when walking or doing stairs) and denied dizziness or other neurologic sensations. Due to persistence of chest and throat pressure, family called nursing line for his PCP who recommended ED evaluation. Mother notes she feels patient has been breathing faster.   No family history of bleeding/clotting disorder. Patient denied leg pain or calf swelling. Notes he has had a headache since his COVID booster and has otherwise been relatively active.   ED Course: Due to fever and chest pain after receiving COVID booster vaccine there was concern for post vaccine myocarditis. Troponin and NT pro BNP were elevated at 0.888 and 979. An EKG was performed and showed ST segment elevation and PR depression consistent with acute pericarditis. CXR without cardiomegaly. Cardiac ECHO showed Mild-moderately reduced LV function with LV dilation, trivial MR.  No effusion. Patient was given a dose of toradol and transferred to the hospital for further care. "
Hives on face; This is a spontaneous report from a contactable consumer, the patient. A 40-years-old male patient received first dose of BNT162B2 (PFIZER BIONTECH COVID 19 mRNA VACCINE Lot number: unknown) via unspecified route of administration in the left arm on 18Mar2021 at 14:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient was not tested positive for COVID-19 since the vaccination. The patient was allergic to Ibuprofen, Tylenol and Aspirin. The patient was experienced hives on face on 18Mar2021 at 18:30. It was unknown if patient received treatment for the event. The clinical outcome of the event hives was unknown. Information about lot number cannot be obtained. No further information is expected.
On Jan 19, 2018 my Pap Smear results came back as negative/normal. A little over a year later on June 6, 2019 I received the Gardasil 9 vaccine, 2nd dose August 19, 2019, and 3rd dose December 26, 2019. 2 years later after getting these vaccines, on June 17, 2021 I receive results back from my next Pap Smear which shows Epithelial Cell Abnormality HSIL: High Grade squamous intraepithelial lesion. These were my signs and symptoms reagrding these vaccines after only 2 years later. I also recived 1st Hep A on June 17, 2019 and 2nd Hep A on December 26, 2019. Which I have listed below
pt recvd vax 30MAR93 & 7APR93 exp malaise & fatigue; 10APR93 devel mumps in lt parotid gland; No further details were provided;
Started with Rash, pain in joints, lymph node swelling, sores in her mouth. She was instructed to see her MD and did not think it was necessary until 6/25/2015 when she agreed to call MD.
Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided Treatment information was not provided Action taken with mRNA-1273 in response to the events was not applicable. The vial was first punctured on 05-Sep-2021 11am Kept in Refrigerator.Total amount of time the vial was exposed to room temperature range (46° to 77° F) from 06-Sep-2021 9:00AM and discarded vial after 4:30PM.   This case was linked to MOD-2021-311383 (Patient Link).
Patient called the clinic to report that she was given a SHINGRIX vaccine at the pharmacy on Tuesday 5/11/2021 after her clinic visit here with the doctor and developed swelling, pain that is a 6, red blotches below the injection site, tenderness, and itching. Doctor recommended the patient take Benadryl 25 mg, 1 tab now and Ibuprofen 200 mg, 3 tabs q 8 hours as needed for pain. If she develops more swelling, fever, chills to go to urgent care or ER (5/14/21). The reported symptoms were consistent with localized reaction to vaccine. Clinic nurse followed up with patient on 5/15/21. The patient stated the symptoms had already resolved.
Diffuse Aches & Pains starting same day as vaccination, still present at time of reporting on 6/12. Nausea, Headache, moderate to severe still present at time of reporting. low-grade fever (self reported as high 99's on 6/9) resolved as of 6/9. Hand numbness on injection arm starting from the morning after injection (6/9) and resolving by the next day (6/10).
12 hours after the vaccination, I had fever, chills, headache, myalgias, dry cough, nausea, decreased appetite, nasal congestion.
some difficulty breathing/Shortness of breath; Severe hives all over body; throat tightening; hot flash, feeling hot; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) dose 1 intramuscular, administered in the left arm on 23May2021 at 12:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 19Jun2021, the patient experienced some difficulty breathing/shortness of breath (disability, life threatening). On 12Jun2021, the patient experienced hot flash/feeling hot (disability, medically significant). On 12Jun2021 at 02:00, the patient experienced throat tightening (non-serious), and severe hives all over body (disability, medically significant). Severe hives all over body started on 12Jun2021, on the 20th day since the vaccination date. It lasted 4 days after taking hydroxyzine, famotidine, and prednisone. Then throat tightening started happening afterwards with some difficulty breathing. Took some OTC antihistamines (Benadryl, Allerclear) to ease the symptom. The patient recovered from the events, hot flash/feeling hot, some difficulty breathing/shortness of breath, and severe hives all over body. The patient was recovering from the events, throat tightening.
The patient had generalized pain, cramps, abdominal pain and dizziness for about 2 weeks.
This case was reported by a other health professional and described the occurrence of wrong vaccine administered in a 4-month-old female patient who received FLUARIX (batch number LM55C, expiry date 23rd June 2015). On an unknown date, the patient received FLUARIX. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information: FLUARIX was inadvertently administered to a 4 month old instead of PEDIARIX.
Got body aches, undocumented fever the night of vaccine which lasted 8 hrs.