chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine was not that effective/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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in the past). Previously administered products included shingles vaccine (received first shingles vaccine when it was first out).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: vaccine was not that effective/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 resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 17-Sept-2023  The case was received form the patient via interactive digital media. The patient's physician said that the vaccine was not that effective and not to get anymore if offered.  The patient had the other 2 vaccines several years ago and just got over the shingles. The patient did not understand why physician keep pushing to get it. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Pt received DTaP #4 5/10/08 -> 5/11/08 with swelling & redness at vaccine site -> 5/12/08 with rash all over.  No subjective fever per mom.  Pt brought into clinic 5/16/08: Temp=99.6, on exam with diffuse urticaria.  Rx'd BENADRYL 12.5/5 ml 1 tspn Q6 hours PRN & hydrocortisone cream.  Will follow up in clinic 5/20/08.
very sore upper arm for about 1/2 hour after 5 hours quickly increasing fever and uncontrolable shivers for 1 hour after 8 hours fever topped at 101.7 continueing nausia and fatigue the next day with low fever and low appetite continuing nausia and fatigue the third day  tinitus the third night lingering fatigue and low appetite the forth day (today)
This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes on left side of neck enlarged), PAIN (body ache), LYMPHADENOPATHY (swelling in the lymph nodes of the right side), INSOMNIA (hard time sleeping) and MALAISE (malaise) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter.  Concomitant products included fish oil and collagen peptide powder for Cholesterol, levothyroxine for Thyroid therapy, ergocalciferol (vitamin D), tocopherol (vitamin E), women's multivitamin, probiotic capsule, aspirin, calcium, niacin and atorvastatin for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INSOMNIA (hard time sleeping), CHILLS (chills), VACCINATION SITE PAIN (Sore left arm, 6 hours after the vaccine) and NAUSEA (nausea). On 10-Apr-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes on left side of neck enlarged), PAIN (body ache), MALAISE (malaise), PYREXIA (Slight fever), HEADACHE (Dull headache) and FATIGUE (fatigue). On 11-Apr-2021, the patient experienced LYMPHADENOPATHY (swelling in the lymph nodes of the right side). At the time of the report, LYMPHADENOPATHY (Lymph nodes on left side of neck enlarged), PAIN (body ache), LYMPHADENOPATHY (swelling in the lymph nodes of the right side), INSOMNIA (hard time sleeping), MALAISE (malaise), CHILLS (chills), VACCINATION SITE PAIN (Sore left arm, 6 hours after the vaccine), NAUSEA (nausea), PYREXIA (Slight fever), HEADACHE (Dull headache) and FATIGUE (fatigue) outcome was unknown. The treatment medication was Tylenol 325mg for symptoms. Action taken with mRNA-1273 in response to the events were not applicable. This case was linked to MOD-2021-073673 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: ADR Form; Sender's Comments: MOD-2021-073673:first dose case
PATIENT ARM WAS RED AND IRRITATED & HAD A SMALL LUMP AROUND THE VACCINE AREA.
Patient received her first flu shot in her life on 11/13/2010 and her second dose on 12/14/10. Prior to receiving the flu vaccine she was healthy. Soon after 2/2011 she was hospitalized & diagnosed with Type I diabetes.
fibromyalgia, diabetes, high BP, chronic myofascial synd, possible lupus;
Itching; A spontaneous report was received from a physician concerning a 59-year-old female patient participating in the mRNA-1273 who experienced itching.   The patient's medical history, as provided by the reporter included shellfish allergy, arthritis, allergic rhinitis, chronic back and shoulder pain.  No relevant concomitant medications were reported.   On 27 Dec 2020, approximately 8 hours prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Dec 2020, the patient experienced itching. After self-treatment, she continues to itch, but it was getting better. Treatment for the event included methyprednisolone acetate and diphenhydramine hydrochloride.   Action taken with mRNA-1273 in response to the event was not reported.   The event, itching, was considered recovering/resolving.; Reporter's Comments: This case concerns a 59-year-old female patient with a relevant  medical history of shellfish allergy and allergic rhinitis, who experienced a non-serious unexpected event of pruritus. The event occurred approximately 8 hours after receiving the first dose of mRNA-1273, lot # unknown). Treatment for the event included methyprednisolone acetate and diphenhydramine hydrochloride. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. Of note, the patient's medical history of shellfish allergy and allergic rhinitis are considered as risk factors.
5/2/2021 - productive persistent cough and poor appetite.  Received physician order to transfer to Hospital for evaluation.
Patient received the expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient received the expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Initial itch which went away within minutes. No symptoms until a sore arm until today (a week later). Arm swelled and raised with hard white surface.  I took a photograph.
several red, itchy blotches on arm and back. No treatment. I was told this is normal
Patient supposed to receive flu shot , but received covid shot. This had hapenned because she identified herself as a different person.
Product storage error; Expired moderna vaccines administered to 5 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccines administered to 5 patients) and PRODUCT STORAGE ERROR (Product storage error) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccines administered to 5 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccines administered to 5 patients) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   On 28-Dec-2021, vials were moved from freezer to refrigerated conditions   No concomitant medications were reported  No treatment medications were reported  The vial did not undergo any temperature excursions   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2022: Followup document contain secondary reporter Info and refrigeration date were updated
Began with itching and patches of flat rash that appeared in different places around the body.  On 11/3/2021, patient noted lumpy spots on scalp that itched a lot. Around 1800, patient had a ?gushing? bloody nose that took around 30 mins to contain. Hives and welts began to nape, wrists, buttocks, torso around the same time, progressing to face by 0130 on 11/4/2021. By 0600 on 11/4/2021, patient?s right eye was swollen shut and upper face and head was visibly swollen. Patient seen by Dr at Clinic at 1300 on 11/4/2021. Patient received a Kenalog Injection (40 mg) in the clinic and prescribed Zyrtec 10mg once daily in pm, Allegra 60 mg once daily in am until hives and welts absent for 72 hours.  Patient woke on 11/5/2021 with increased swelling and hives, more generalized to entire face, forearms and legs, as well as spots of same across torso, groin and buttocks. Patient has complained of intense itching and pain since 0130 on 11/4/2021. Dr added an Allegra 60mg daily at midday, and oral prednisone 20mg once daily with food x5 days. Patient has follow up visit with Dr. on 11/8/2021 at 1100.
Three hours later, I got a real bad headache and had it for about a week. I took Tylenol for it. Fever also - had it the rest of the first day of the vaccine. I didn't have the ability to do my regular daily things for three days. I felt really bad.  Afib symptoms - I was admitted to the hospital ER (2/15/2021) twice and I had Afib symptoms and my heart was severe (it was stopping to beat for over 5 seconds). My PPM would go from 53 to 157 in split second and then it would go into pause where my heart would stop beating. That happened where I was in the hospital for 4 days. They couldn't get it under control so they gave me a pacemaker - Date of Pacemaker was May 22. And then they continued (my Afib continued). July 14th -  after getting pacemaker, I had a  Cryoablation - .( I had the second 2/24/2021 - Lot #EN6203.) I have a heart monitor for my pacemaker and I continue to have some palpitations and some events but nothing that I have had to go back to the hospital for.  And I guess that is normal for my condition. From that, now I'm on the same ones and added:  Amiodarone - 200 mg;  Xarelto - 20 mg.
No symptoms or adverse effects reported; patient received unspecified dose ofVARIVAX that was improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent  On 15-OCT-2019, the patient was vaccinated an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S003447, expiration date 04-FEB-2021; strength, dose, route were not provided) for prophylaxis (product storage error).  Temperature excursion of this vaccine was -12.8 degree Celsius for 2 hours and 38 minutes. There was previous temperature excursion and the worst previous temperature excursion was -9.8 degree Celsius for about 112 minutes. No symptoms or adverse effects reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA000010:
1st dose Sep/2022, not received 2nd shot yet; Patient born in 1975 received Shingrix on Sep-2022; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In SEP-2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In SEP-2022, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient born in 1975 received Shingrix on Sep-2022). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: 1st dose Sep/2022, not received 2nd shot yet). The outcome of the inappropriate age at vaccine administration and incomplete course of vaccination were unknown.   Additional Information: GSK Receipt date: 08-MAY-2023 The patient received Shingrix vaccine who was younger than the indicated age which led to inappropriate age at vaccine administration. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did consent to follow up.
patient says her lips were extremely swollen from inside and outside , 45 minutes after the shot. She could Not swallow because of her lips, but her throat was not swollen
24 hours later, patient and wife had plans and patient stated that he was not feeling well, generally.  Wife then states that he did complain of leg pain since they had been driving in the car.  05/30/2021  Patient presented to ED and was found to have DVT and extensive PEs
Hard itchy red lump at vaccine site appeared 8 days after vaccine.  Currently about 3 inch diameter across upper arm.
103.9 axillary temperature, O2 sat 92-94% on room air seizure. Follow up on 12/10/03: "Date and time of first seizure after flumist administration: 11/13/2003 after 6PM, child in bed at time.  Time interval between flumist vaccination and onset of seizure: 12 hours.  The seizure was generalized in both sides of the body.  There was postictal drowsiness.  Parents report: unresponsive, eyes rolled back in head, tonic-clonic contractions of extremities lasting several minutes.  Child felt warm at 6PM given Tylenol.  Seizure lasted "several minutes".  Tylenol medicine was administered before the seizure started.  Date of first clinic/ER/hospital visit for the reported seizure: 11/13/2003.  Diagnosis made by ER physician.  Non recorded in seizure activity in ER.  Diagnosis noted either on the date of first clinic/ER/hospital visit following the seizure episode or within 4 weeks afterwards: Upper Respiratory Infection; Acute Sinusitis; Acute Bronchitis; Febrile Seizure;
On Thursday 03/30/2006 sent from day care with temperature of 102 degrees.  Friday 100.5 degrees, Sunday 102 degrees.  Developed rash on cheeks, Sunday some on abdomen, back, and legs, lymph glands swollen.
lt arm area red, swollen, warm to touch;pt denies discomfort sx started this AM;parent brought child into PHD for nurse to examine;parent reports no fever;instructed to apply cool compress to area several times daily;if sx worsen contact PM
Very sore right upper arm. Skin turned very red and swollen. Called Dr. lasted about 3 days.
Mom called on-call nurse (after hours) and reported child having allergic reaction to HPV vaccine that was given in office some 8 hours ago. Sx were edema & numbness (L) side of body (arm, neck, leg) with difficulty swallowing pt sent to ER.
Information has been received from an 81 year old male who on 16-OCT-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included cyanacobalamin injection and other unspecified medication. On 19-OCT-2007 night the patient experienced headache, sweating itching and tingling on top of his chest and arms that went away after 2 to 3 hrs. The patient stated that he did not have any rashes. No diagnostic laboratory tests were undertaken. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
pt presented to office with a reaction she believes came from her getting the Pneumovax 23.  pt arm was red at injection site which went around arm and some pain at site which resolved with Tylenol, some arm pain when lifting and this has improved.
A mother reported that her 2-month old son received Rotashield, DTP, Hib, IPV vaccines on 7/12/99. He developed stringy and slimy stools. On 9/6/99, he developed vomiting and diarrhea. He was taken to the ER where a spinal tap, rotavirus test and barium enema were performed. A dx of intussesception was made and surgery was performed. He was hospitalized and spent one week in the ICU. He recovered. He recently developed vomiting, diarrhea and blood and mucous in his stool and was taken to the ER. The indicated that the child's formula was recently changed to Isomil. A copy of this report has been forwarded to PMC, (manufacturer of IPV vaccine.) This report of a serious labeled event is being submitted in a 15-day time frame.
Patient presented with SOB and low blood sugar. Patient was positive for COVID and fully vaccinated. Not boosted
I had migraines for a good amount of time post vaccination. I was not prescribed medication. I just took acetaminophen. I am still dealing with the migraines at this time.
Vesicular rash on diaper area -- treated with reassurance, isolation from pregnant patients/unvaccinated children.
three doses of Pfizer vaccine- #1 1/6/21- in facility  #2 2/24/21 #3 3/18/21
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Moderna vaccine on 4/05/21, 5/03/21, and 12/1/21. Prior admission to ED c/o of feeling more tired than normal. Transferred from Hospital for sepsis 2/2 spontaneous bacterial peritonitis, COVID-19, AKI and decompensated cirrhosis. RRT called overnight on 9/18 for AMS in setting of hepatic encephalopathy and new signs of GI bleed. He became A&Ox0 with increased WOB.  Transitioned to DNAR/AND and transferred to inpatient hospice.  Expired on 9/24/22. Tx'd with remdesivir and ceftriaxone.
Cough; Fever; Chills; Body aches; This is a spontaneous report from a contactable consumer. A 28-year-old female patient receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration at left arm from an unspecified date at a single dose for COVID-19 immunisation. The patient had no medical history. The patient is not pregnant. There were no concomitant medications.  On an unspecified date, after first vaccine for two weeks, the patient had a cough, couple days of fever, chills and body aches. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Information has been received from a female patient who on an unknown date was vaccinated with GARDASIL. "15 months from the completion of the GARDASIL vaccination" the patient had full blown cervical cancer. The patient's oncologist would like to do a hysterectomy at this time, but the patient stated that she always wanted children. The patient had chosen to wait. The patient stated that she had two of the strains that the shot was supposed to prevent. At the time of reporting the patient had cervical cancer. The outcome of the patient's cervical cancer was not reported. Upon internal review the patient's cervical cancer was considered to be other important medical event. Additional information has been requested.
A week after my vaccine, all of a sudden I couldn't breathe, couldn't even walk from room to room. I also had body aches, and kept coughing, my heart raced as well for a week. I usually only use my Oxygen a couple times a week at night, but now I was using it during the day. I didn't see my doctor, I decided to wait it out.
4x6 red rash between shot and elbow toward center of arm. Thumb & back of hand swollen & itchy with no grip. Fingers swollen & tingly. Called office but they had already closed.
MASSIVE STROKE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total, administered in APR-2021 (about eight days prior to this report) for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  It was reported that, in APR-2021, the patient had a massive stroke and died. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: - Covid-19 Vaccine Ad26.Cov2.S - Massive Stroke. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: MASSIVE STROKE
A report was received from a healthcare professional on 10/24/2002, concerning a 26 year old female vaccinee who experienced warmth, tingling, redness and soreness and developed a softball-sized lump at the injection site after receiving Fluvirin intramuscularly on 10/23/2002. On 10/23/2002, the vaccinee experienced warmth, tingling, redness, soreness and a lump at the injection site after receiving 0.5ml Fluvirin intramuscularly on 10/23/2002.  It was reported that the attending physician suspected that the vaccinee may be allergic to the drug.  The vaccinee has received an influenza vaccine for the past 6 years without any problems.  Symptoms had not resolved at the time of the reporting. There was insufficient information to determine the reporter's causality assessment.
Next day he felt drowsy. He was weak, had a fever, aches. His arm became very red, very sore and painful. Patient is still weak two weeks later.
pt recv vax & pt devel zoster virus (shingles) post vax;f/u was recv which indicated pt only had a 5yr old & was already filled out & sent off;
After approx 6 hours some arm pain; after approx 16 hours, extreme arm pain; approx 24 hours later feelings of overall sickness/lethargy; ~30 hours after, 100. 1 fever, chills, headache, restlessness through the night. Morning (approx  43 hours after vaccine, now, feeling somewhat better, still with headache.
All my joints are hurting, no fever, mild swelling.  I have been using ibuprofen 800 mg 3x daily with minimal relief. This pain is close to my crps diagnosis. I cannot get out of chair, car, stand very long, basically stuck because joints hurting so bad