chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Have them now, had vaccine too/had shingles/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Have them now, had vaccine too/had shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-Mar-2023 The case was received from the patient via interactive digital media. The patient had them now and had vaccine too. The patient had surgery and few days later had the shingles. The patient stated that terrible. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
No adverse reactions for over an hour.  Acute bone ache, chills, lethargy;  flu like symptoms though no elevated temperature, no joint aches.
2nd COVID-19 vaccine administered in 3 injections in 10%, 30% and 60% of full dose. 10% of full dose left arm. Symptoms occurred after a few minutes of mouth, throat/tongue swelling and body/face rash. Waited for symptoms to decrease prior to next injection. No treatment. 30% of full dose right arm, same symptoms worsened following injection (oral swelling and rash) and mild tiredness also started. Waited again for symptoms to wane prior to final injection. No treatment. 60% of full dose left arm oral swelling and rash worsened again immediately following injection. Tiredness increased. Allowed to sleep during 1-hour observation period. Zyrtec and albuterol taken prior to discharge.
Information has been received from an office administrator, concerning multiple unspecified patients (unknown age and gender). No relevant medical history or concurrent conditions were reported. Starting from an unspecified date in 2015, these patients were vaccinated with improperly stored VARIVAX (lot numbers, expiration dates, dose numbers, doses and routes were not reported; temperature/time frame: 30 Fahrenheit/312 hours, call not because of data logger). No adverse effects were reported. Additional information has been requested.
Fever, chills, flu like symptoms, diffuse body ache,  malaise.  Lasted 1 day
patient experience blurred vision, difficulty breathing, light-head, ringing in the ear, arm is numb, anxiety.  Called 911, EMT came and checked him out, vital signs are normal.  pt refused to go to ER.
Burning feeling in legs that come and go (sometimes severe), fatigue, numbness in calf that lasted about 5 hours, large red lump that feels hot to touch under skin where I received vaccine. The lump is painful and itchy.
Developed a cold; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Developed a cold) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced NASOPHARYNGITIS (Developed a cold). The patient was treated with IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (ADVIL COLD) for Cold, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Developed a cold) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: NNI received
2/1/2022 patient presented to ER for suicidal ideations. Tested positive for Covid-19.
Profuse sweating; Vomiting; Very high fever 103F to 104F; Bad chills / Rigors at nights; Little headache; This spontaneous case was reported by a patient and describes the occurrence of HYPERHIDROSIS (Profuse sweating), PYREXIA (Very high fever 103F to 104F), CHILLS (Bad chills / Rigors at nights), VOMITING (Vomiting) and HEADACHE (Little headache) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concomitant products included COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA), TESTOSTERONE and CYANOCOBALAMIN (VIT B 12) for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced HYPERHIDROSIS (Profuse sweating), PYREXIA (Very high fever 103F to 104F), CHILLS (Bad chills / Rigors at nights), VOMITING (Vomiting) and HEADACHE (Little headache). On 07-Apr-2021, HYPERHIDROSIS (Profuse sweating), PYREXIA (Very high fever 103F to 104F), CHILLS (Bad chills / Rigors at nights), VOMITING (Vomiting) and HEADACHE (Little headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment- Received Tylenol medications for the adverse reactions developed   This case was linked to MOD-2021-102013 (Patient Link).
administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA462A, expiry date 31st October 2021) for prophylaxis.   On 2nd November 2021, the patient received Menveo. On 2nd November 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: Nurse Manager called in to report:  They inadvertently administered an expired dose of Menevo to the patient, which led to expired vaccine used. The reporter did not consent to follow-up.
Two day expired Jynneos vaccine was administered to patient on 11-Aug-2023, expiration date 08-Aug-2023; Case reference number US-BN-2023-001402 is a spontaneous case report initially received from nurse via Communications (reference number: USBAV23-1225) on 15-Aug-2023 and concerns an adult male.  The patient's medical history and concomitant medication details were not provided.  On 08-Aug-2023, Jynneos vaccine expired.  On 11-Aug-2023, the patient was vaccinated with a dose of expired Jynneos vaccine (batch number: FDP00020; expiration date: Oct-2024), at unknown dose, route and site of administration, for indication reported as Monkeypox vaccine (explicitly coded as 'expired vaccine used'). On the box, expiration date was Oct-2024. The best use date was 08-Aug-2023 and was handwritten. As reported, it was delivered by health department to office at 13-Jun-2023. The reporter taught that must have been the date the vaccine was pulled from frozen storage and then sent.  At the time of initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received from Bavarian Nordic on 17-Aug-2023 included local BN case ID number.; Reporter's Comments: A 23-year-old male patient was vaccinated with a dose of Jynneos (batch FDP00020, best use date 08-Aug-2023), on 11-Aug-2023, three days after the best use date, which is considered expired vaccine used. On the box, expiration date was October 2024. No associated adverse events were reported. Expired vaccine used is considered listed per company convention. Medical history was not reported. Expired vaccine used is considered not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: A 23-year-old male patient was vaccinated with a dose of Jynneos (batch FDP00020, best use date 08-Aug-2023), on 11-Aug-2023, three days after the best use date, which is considered expired vaccine used. On the box, expiration date was October 2024. No associated adverse events were reported. Expired vaccine used is considered listed per company convention. Medical history was not reported. Expired vaccine used is considered not related to Jynneos, but to human error. The case is non-serious.
pain in every  joint and muscle stiffness, and back night sweats, lasted about 15 hours .  48 hours after receiving vaccine still achy but tolerable
Patient with 3 COVID vaccines who admitted with COVID detected test.  Provider d/c note: "87 yo male seen with Wife with PMHx parkinsons with PEG feeding tube, indwelling chronic foley, dementia, diabetes -2, CADs-CABG, remote stroke, HTN, CKDs, COPD with 3 prior hospital admissions in 2022 who states he bumped his left leg on a cement block last week Thursday. He was seen in the clinic the wound and placed on keflex however he states the leg has become redder and more swollen. He denies sig pain,chills or fever. He is admitted with a erythematous L distal cellulitis with hematoma with likely abscess formation with GS consult. He is fully covid vacc + booster (HPI per Dr)   Hospital Course: No notes on file LLE contusion   Hematoma formation s/p I and D 7/21.  daily dressings, pain control, no antibiotics indicated per Dr.     Incidental Covid 19 + mild cough, fully vaccinated monitor clinically. No hypoxia. Increasing oral secretions."
Diarrhea and abdominal cramping 1 hour after second dose of Covid vaccine. Took OTC medication, Imodium, motrin, soft bland diet.  Six + episodes of diarrhea in one hour on 1/21/2021 with significant cramping.  Went to ER.  Received fluids and IV Zofran.  CBC and CMP WNL.  Stool test also done--negative.   Discharged.  Severe diarrhea morning of 1/22/2021.  Missed work on 1/21 and 1/22.  Diarrhea and abdominal cramping continued intermittently. Worked Monday.  Stool samples provided.  C.Diff negative.  Lactoferrin positive. Enteric bacterial panel negative.  CT of abdomen scheduled for 1/27/2021
Vaccine given at 6:45pm.  Approximately 3 hours later, began experiencing cough/wheezing.  This progressed through the night until around 4am, both eyes were very bloodshot and fluid discharge.  Also head congestion and rapid heart beat.  Took loratadine 10mg at 10:30pm.  Symptoms resolved upon waking in the morning.  This is the first time that I have had the flu vaccine.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE UNSTABLE ANGINA ACUTE NON ST ELEVATION MI ACUTE CORONARY OCCLUSION WO MI 3/6/2023 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Information has been received from a consumer reported "she knows several children (exact number is unknown) who experienced a high fever and were diagnosed with autism a couple months after receiving a dose of MMR II. Upon internal review, autism was determined to be an other important medical event. This is one of several reports from the same source. No further information was available.
Pt developed headache, nausea, irritability, stiff neck, vomiting, sleepiness all the time, and loss of peripheral vision. Doctor's won't conclude 100% that it was due to Hepatitis B vax. FU states pt has severe optic neuropathy OD and mild optic neuropathy OS, both secondary to parainfectious meningitis with increased intracranial pressure. Per doc 213384, 60 day follow-up, no further information is available. Per annual follow up: pt has not recovered. He has some permanent visual (optic atrophy) impairment.
we got deathly ill; Initial information received on 30-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (wife of the patient).  This case involves a male patient of unknown age who got deathly ill (illness), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  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 in unknown administration site for prophylaxis vaccination.   On an unknown date in December 2017, (latency unknown) after the administration of suspect vaccine therapy, the patient got deathly ill (illness) through Christmas and new years (severity: severe).  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.     There will be no information available on the batch number for this case.
80 yo M comes to clinic with 4 days hx of swelling and erythema over b/l wrist and thumb. Pt says it started 4 days ago over left wrist and thumb and then 1 day later it also occurred on right wrist and thumb. It is a/w pain on movement of hand over wrist joint and thumb. The swelling and erythema over left hand has been decreasing progressively and almost reduced to none, while the right hand still has swelling and erythema. Pt denies any trauma, no new medications or foods, no hx of exposure to any new substance. Pt says that he had flu shot on Wednesday, 2 days before the swelling started. Pt has had flu shots in past years but never had any allergic reaction. No fever, chills, n/v, no itching. No other joint swelling or erythema.
sore; warm.; red spot; swollen; hard; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore), INJECTION SITE WARMTH (warm.), RASH MACULAR (red spot), SWELLING (swollen) and INDURATION (hard) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN (sore), INJECTION SITE WARMTH (warm.), RASH MACULAR (red spot), SWELLING (swollen) and INDURATION (hard). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN (sore), INJECTION SITE WARMTH (warm.), RASH MACULAR (red spot), SWELLING (swollen) and INDURATION (hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
My immune system and Immunoglobin levels began failing. An infection raged after PRIVATE training. 21 days of anti-biotics. cleared the infection. I was referred to an immunologist. Immunoglobin A did exist in my immune system. Over the next year until May 2022 my immunoglogbin levels continued to fall. Subtypes of IgG continued to fall, IgM continued to fall. Attempts were made to get immune response with hyper vaccination of Prevar 13, Prevnar 20, and HEB vaccines. Nothing worked. My only option was to receive monthly infusions of Gammagard S/D.
pt reported feeling rapid heart rate and faint. Skin cool and clammy, pt assisted to lie down, HR 130's, BP 134/78. c/o feeling pressure in throat. Rapid response called and patient assisted to stretcher and transported to ED.
Pt received Moderna booster 1 day before 18th birthday. No adverse events noted. Pt was understanding when issue was brought back to her attention.
I experienced 4 hours after the vaccine severe headache, severe nausea, severe weakness, severe fatigue, severe body pain. It lasted for about 24 hours. The headache lingers. I couldn't eat or drink for 20 hours. I was struggling to walk the pain and fatigue was so bad. I also had fever over 101. For 3 weeks I had  nausea and headaches on and off.
Fatigue, Lethargy, unusual (or metal) taste in my mouth (3 days) Difficulty swallowing for a few hours. Itchy skin on faces, head and legs for about 4-5 hours.. Still unusual taste in my mouth as of 5/27/21.
morbiliform eruption;ruddy pharynx;n/v;T100.5 R;
States site of immunization R upper arm reddened & warm. Size 3 to 4 cm dia. No induration. Erythema and mild tenderness.
Injected IM at Pharmacy on Saturday AM, in perfect health.  As of Tuesday (9/3/2019), sore throat, sinus and lung congestion, tired, lethargic and significant joint pain (arms, legs, back).  No knowledge of contact with ill individuals.   No known allergies and no occurrence of flu during the past 5 years with annual High-Dose Flu injections.  Believe there is a likely correlation between High-Dose Influenza injection and occurrence of flu-like symptoms.
RECEIVED VACCINE VARICELLA AND TDAP - ON 9/16/2011 - APPROX 3 HOURS LATER CLIENT WAS S.O.B. AND LEFT ARM HAD SWOLLEN. SHE WENT TO ER AND THEY GAVE HER BENADRYL IM AND HYDROCORTISONE TO AREA WHERE SHOTS GIVEN. LG SIX INCH REDDENED AREA WHERE VARICELLA WAS NOTED - AREA STILL WARM TO TOUCH. DR STATED "NO MORE SHOTS"
Fever; headache; Chills; Dose number = 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2), administration date: 27Jan2021, when the patient was 25 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1), administration date: 04Jan2021, when the patient was 25 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "Dose number = 3"; PYREXIA (non-serious) with onset 15Dec2021, outcome "recovered" (Dec2021), described as "Fever"; HEADACHE (non-serious) with onset 15Dec2021, outcome "recovered" (Dec2021), described as "headache"; CHILLS (non-serious) with onset 15Dec2021, outcome "recovered" (Dec2021), described as "Chills". Therapeutic measures were not taken as a result of pyrexia, headache, chills.  Additional information:Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Muscle aches - began approximately 7 hours after vaccination. Continued until next morning.  Chills - began approximately 10 hours after vaccination. Continued until next morning.
The day after my vaccination I had really bad chills, I assume I had a fever and extreme fatigue. I was in bed for most of the next three days. Body aches all over and it felt like my bones hurt. I would say about four days out from the vaccine I started to improve and feel much better. These symptoms lasted for about 72 hours. Heart palpitations had occurred as well. I did have some lymph swelling in my neck and armpits for about a month. I am only dealing with post COVID-19 symptoms now at this point.
Headache, malaise. 5cm by 9 cm redness and warmth with 3 cm by 3 cm central papular patch. Treated with Keflex without improvement. Treated 24 hours later with Acyclovir with rapid improvement in 12-24 hours.
ITCHY; EXTENDED HAND SIZE RED PUFFY PATCHES IN SEVERAL SPOTS AROUND UPPER LEGS AND HIP AREAS; RASH INCREASING IN SIZE; WELTS INCREASING IN SIZE ESPECIALLY AT NIGHT; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via another pharmaceutical company concerned a 72 year old male. The patient's weight, height, and medical history were not reported. On 10-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, 1 total administered for covid-19 prophylaxis. The age at time of vaccination was 70 years. It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (dose number in series: 1). On 21-OCT-2021, the patient received non-company suspect vaccine elasomeran (Moderna vaccine) (dose number in series: 2) (form of admin and route of admin were not reported, batch number: 039021A expiry: UNKNOWN) dose was not reported, administered for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date in 2022, the patient experienced covid-19 (coded as suspected covid-19) (dose number in series: 2). On 22-JUN-2022, the patient was initiated treatment with non-company suspect drug Paxlovid (form of admin, route of admin and batch number were not reported, expiry: unknown) dose was not reported, administered for covid-19. On 24-JUN-2022, the patient experienced rash increasing in strength each of the five day treatment, itchy welts increasing in size especially at night resulting in extended hand size red puffy patches in several spots simultaneously (dose number in series: 2). On 27-JUN-2022, the patient completed the five day treatment of Paxlovid. The action taken with covid-19 vaccine ad26.cov2.s and elasomeran was not applicable, and action taken with Paxlovid was not reported. The patient recovered from itchy, extended hand size red puffy patches in several spots around upper legs and hip areas, rash increasing in size, and welts increasing in size especially at night on 2022, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
This spontaneous report was received from a medical assistant concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, unspecified patients were vaccinated with improperly stored doses of GARDASIL (dose, route, Lot No. and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received ZOSTAVAX in left tricep on 12/7/12. Within 12 hours swelling and redness occurred progressing steadily to 8 in long / 5 in wide. It is warm to the touch & itchy.
Not feeling well after the 2nd dose; Bad sore throat (strep) after the 2nd dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well after the 2nd dose) and PHARYNGITIS STREPTOCOCCAL (Bad sore throat (strep) after the 2nd dose) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Not feeling well after the 2nd dose) and PHARYNGITIS STREPTOCOCCAL (Bad sore throat (strep) after the 2nd dose). At the time of the report, MALAISE (Not feeling well after the 2nd dose) and PHARYNGITIS STREPTOCOCCAL (Bad sore throat (strep) after the 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact