chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received every Shingles vaccine out there. After receiving Shingles vaccine, the patient got shingles three times. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Admitted to hospital on 7/20/21 with respiratory congestion, dry cough and rhinorrhea after positive COVID test on 7/15.  Resulted in acute hypoxic respiratory failure with death 8/6/21.
No adverse events, no signs or symptoms of reaction after patient given adult dose of Hepatitis B.
Pt reported that pt devel diffuse urticaria following vax; No further details were provided;
"pt recv vax 6JUN97 & pt c/o shooting pains in back of head, hands & fat & abd pain as well as numbness in hands/feet;sx began 1 1/2wk p/vax;pt states saw PMD 7JUL97 who told probably is quirky rxn to inj;abd pain, chest pain,n, dec appetit
This spontaneous prospective pregnancy report was received from a nurse and refers to a currently 24 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies and did not receive any concomitant medications. On 28-JUL-2015 and on 25-SEP-2015, the patient was vaccinated with the first and the second dose of GARDASIL (exact dose and route of administration were not reported, lot # K016966, expiration date 10-MAY-2017). The patient became pregnant with last menstrual period (LMP) of 17-OCT-2015 and estimated delivery date (EDD) of 23-JUL-2016. The nurse reported that on 20-JAN-2016, the patient was seen in the clinic for a prenatal office. The patient received standard prenatal care and had standard blood and urine labs performed. The pregnancy outcome was pending. The fetal outcome was unknown. Additional information has been requested.
Fever, chills, body aches extreme fatigue. Treated with ibuprofen for some relief. Symptoms subsided after approx 16 hours from onset. Red, swollen,  hot, itchy  injection site speeding across majority of upper arm. Swollen arm and lymph nodes  on left side. Relief of soreness with ibuprofen and ice application. Cortisone cream for itchiness.
Mother called and talked to PHN on 8/3/06 after the twins received the Menactra vaccine. Reported that she was at the lakes and her daughters called her from their home.  Reported that the twins' complaints of being "dizzy, sore, weak, and had headaches". She was reassured of the safety of today's vaccines but encouraged her to have the twins follow up with a medical provider for their symptoms. She stated that a VAERS report would be filed.
Very sore at the injection site, light nausea, fatigue, low grade fever, chills, lethargy, body aches.  All symptoms resolved within 24 hours of onset except for sore injection site and fatigue.  I am still having sore injection site and fatigue 48 hours after receiving the immunization.
Developed Shingles 2 days after first dose.; This is a spontaneous report from a contactable nurse, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685) via an unspecified route of administration in the left arm on 30Dec2020 at 12:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Concomitant medication taken within two weeks of vaccination included loratadine (CLARITIN) taken on unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient developed shingles on 01Jan2021, two days after first dose. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with medications like antiviral, antibiotics, pain reliever. Since the vaccination, the patient had been tested for COVID-19. On 16Mar2021, the patient underwent COVID-19 test via nasal swab and the result was negative. The clinical outcome of the event developed shingles two days after first dose was resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Patient states she experienced sharp pain, warmth, and redness at injection site. Within 2 hours she was nauseous and had a headache and was vomiting. She spoke with her doctor over the phone and he recommended an OTC antibiotic ointment because she was concerned the site was injected. He told her to followup at the office with any changes. As of 10/26 when I spoke with her, injection site still red and swollen but no fever or nausea
Pruritic rash to upper back and arms noted last night. Scattered papules; small 1mm, no erythema.
Pt received influenza vaccine on 11/04/2020 at a PCP visit. Later developed rash to patients trunk, and face, constant but mild in severity. No medication administered. No difficulty breathing, change in voice, facial swelling, fever, vomiting, and coughing.
I got really congested, we knew it was just a cold. I did a home COVID-19 test that came back negative, with all that is going around my doctor prescribed TAMIFLU to help me get over what I was going through. It did help, but I am still congested. It may be allergy related.
This spontaneous report as received from a nurse refers to patients of unknown age and gender. On an unknown date, 3 unspecified patients were vaccinated with VARIVAX (Merck) injection, (dose, route of administration and indication were not provided) that was improperly stored. No adverse effects reported. No product quality complaint was involved. The outcome of events was unknown. No further information was provided. Additional information has been requested.
Patient states the morning after the vaccine her arm felt sore, tight and knotted, and feels about the same today, 5 days later. Patient took a muscle relaxer and Tylenol without relief of symptoms
Headache, SEVERE uncontrollable shaking (don't think it was due to being cold), nausea, fatigue, all over achey, hot/soreness at injection site.   Severe symptoms lasted overnight, fatigue and aches lasted for three days.  Could not function enough to get to the bathroom by myself during the night of shaking.  Disoriented to the point of not knowing which direction I was going.  Treated with liquids and Advil.
Lymphadenitis lateral cervical chain and postauricular bilateral. Treated with Advil from 4/1/00 to 4/6/00; resolved. Arthralgia in hands, wrists, elbows, shoulders, knees, ankles and feet. Treated with Advil from 4/5/00 to 4/9/00; resolved. Rash on extremities to trunk from 4/4/00 to 4/8/00. Treated with Benadryl; resolved. Malaise from 4/1/00 to 4/9/00; resolved.
Next day after flu shot, pt felt pain about 1 square inch around the injection point. Later in a week, the pain area expanded, but no more intense. Now the whole upper left arm feel pain if lifting or moving.
t105.2 fever approx 14-16 hr p/inj;sl redness @ site of inj;taken to urgent care;
Severe heartburn, severe headache, body aches, started around 2am day after the vaccine.  Severe symptoms lasted for approx 24 hours, then less severe symptoms persisted for 4 days . Still have mild headaches.
The vaccine was exposed to sunlight; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (The vaccine was exposed to sunlight) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concomitant products included PRAVASTATIN for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (The vaccine was exposed to sunlight). On 13-Apr-2021, POOR QUALITY PRODUCT ADMINISTERED (The vaccine was exposed to sunlight) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient received the first dose of the Moderna COVID-19 vaccine on 13-APR-2021 through a drive-through vaccination facility. He stated that when he received the vaccine, the vaccine was exposed to direct sunlight due to the vaccination provider holding the vial out in direct sunlight. He experienced no side effects.   This case was linked to MOD-2021-135651 (Patient Link).
Dose 1 - Joint inflammation - unable to lift arm above waist high. Took Tylenol until soreness gone  Dose 2 - Chills and body aches for 1.5 days immediately post injection. Took Tylenol until symptoms  gone.  Starting 02/08/21 severe uticaria (underarms and sides, backs of knees, groin, lips, hands) Hands had  blisters. Telemed visit on 02/10/21. Given Medrol pack, Benadryl OTC 1 capsule BID, Pepcid AC OTC 1 tab BID. Taken for two days but not resolved.  Seen again by MD on 02/12/21 and given RX: Cetirizine 10 mg 2 tabs BID, Prednisone 10 mg tab 12  days tapered off starting with 6 first day; Famotidine 20 mg tag, 1 tab BID
PT presented on 3/28/03 to vax site w/small red maculopapular rash on cheeks of face. Started appeared on 3/27/03. Also c/o itchy eyes. Denied Hx of rashes. Referred PT to another health center for Benadryl. Employee health started Pt had presented in past w/similar rash.
Next day has low grade fever, lethargy, extreme soreness in limb injection was given, body aches, headache
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted, and she stated she faints due to needles all the time. She did hit her head and EMS came and checked her out. She opted not to go with EMS and will take herself to ER
Patient described lingering neuropathic type pain that did not subside. Patient will see his orthopedist and let us know the outcome
Fever x 3 d. Swelling of the upper arm - ice, BENADRYL. Dizziness.
Caller said with Covid people were getting sick; sick; cough/ he still has cough; This is a spontaneous report from a contactable male consumer (patient). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date were not reported) via unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Previously patient took first dose of BNT162B2 for COVID-19 immunization. It was reported that he received the 2nd dose of the Pfizer COVID Vaccine on 03Mar2021. Two weeks later, he developed a cough in Mar2021 that was still persistent by the time of the call. He mentioned that he did not have a cough prior to the vaccine and was certain that his prolonged cough was caused by the vaccine. He received his vaccine He was asking if this had been reported and for what to do about it. Again, stated that he took his last shot at a Health Facility. It was the Pfizer last shot on 3Mar2021. He developed a cough 2 weeks later and now it was 14Jun2021 and he still had cough. Patient said with Covid people were getting sick. Patient stated that he was trying to find out what to do about the cough. When caller was advised to consult with primary healthcare professional, caller said that physicians did not know how to treat the cough. It was a vigorous cough. Caller wanted to know if we had seen a cough like this that went on this long and what to do about it. He was taking treatment with cough drops and cough medicine, still coughing, but nothing was working. At the time of report, the outcome of event cough was not resolved, whereas unknown for other events.   Information on the lot/batch number has been requested.
Information has been received from a healthcare worker (immunization official) referring to a 5 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 024-AUG-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K026387 (expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient came back to pharmacy on 9/28/20 and showed me her left arm. It looked a bit swollen and warm to the touch in the area injection was given.
No other AE reported; a temperature excursion involving GARDASIL 9; This spontaneous report as received from a "HBP" refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 16-DEC-2020, the patient was vaccinated with an improperly stored sdose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1602284, expiation date 26-SEP-2021 (also reported as 06-SEP-2021, but upon internal validation established as 26-SEP-2021), 0.5 ml for prophylaxis (route of administration was not reported).  Administered dose of vaccine underwent the temperature excursion of 31.2 degrees Fahrenheit for 30 minutes. Digital data logger was involved. There were no previous excursions reported. No adverse events were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1602284; expirationdate: 26-SEP-2021; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2101USA010328: US-009507513-2101USA010448:
extreme fatigue; muscle aches; severe headaches; irritable; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue), MYALGIA (muscle aches), HEADACHE (severe headaches) and IRRITABILITY (irritable) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included DOXYCYCLINE MONOHYDRATE (DOXYCYCLINE SOLUTION TABLETS) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced FATIGUE (extreme fatigue), MYALGIA (muscle aches), HEADACHE (severe headaches) and IRRITABILITY (irritable). At the time of the report, FATIGUE (extreme fatigue), MYALGIA (muscle aches), HEADACHE (severe headaches) and IRRITABILITY (irritable) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment details included ibuprofen.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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 Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient had all Shingles vaccines and booster, which led to extra dose administered. The patient then got shingles a week ago and never had chicken pox. This case was considered as suspected vaccination failure since the details regarding completion of time to onset and laboratory test confirming shingles were unknown at the time of reporting. Note: From the narrative it was not clear if the patient received all vaccine from gsk or non gsk vaccine. Hence only 2 suspect were coded conservatively, 1 suspect for all vaccine and 1 suspect for booster dose and no extra dose was coded as an event.
approx 5 minutes after vaccine developed an erythematous rash entire body; hive like on upper chest and back
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient not regularly receiving care in the system to make a determination for cause of death. Comorbidities include advanced age, hypothyroidism, asthma, HLD, HTN, and GERD.
I waited the recommended 15 mins as having no prior issue with anaphylaxis. 20 mins after the vaccine, I was driving and started itching on the left side of my neck. I didn?t notice any face, lip or throat swelling and continued to pick up my child from school. An hour after the injection, the itching was felt all over my body not localized. I called my doctor to ask if I could take Benadryl. He agreed. The itching continued and red blotchy skin could be observed all over body. About 4 hours after injection, I experienced body aches that lasted an hour and then subsided. 8 hours after my injection, most of the itching and blotchy skin had subsided
Starting 07/28/2022, I developed a sore throat. On 07/29/2022 - 07/30/2022, I developed a fever. I never had shortness of breath or cough, just a runny nose. I was tested at CVS on 07/29/2022 and it was positive. The fever lasted for about a day and a half and went away on its own. I did a telehealth visit on that Tuesday and was prescribed Paxlovid. I did it for 3 of the 5 days then stopped. I got a really bad metallic taste in my mouth causing me to not eat. Therefore, I stopped taking it.
Patient claims that he wants to get is first dose of COVID vaccine, and request Janssen. Janssen dose was administered on 6/8/2021. Upon billing the vaccine, the pharmacy noticed that the patient already received 2 doses of Pfizer COVID vaccine in March 2021. Patient then admitted that he did received 2 doses of Pfizer COVID vaccine, and heard online that there will be higher potency if 2 different manufactures of COVID vaccines are administered. Patient claims that he doesn't experience any adverse reaction at the moment.
Per Mom, patient developed temp of 100.3 the morning after the vaccinations were administered. Denies other symptoms. Advised to give tylenol every 4-6hr PRN and to call back with new/worsening symptoms/questions.
chills & fever, nausea & vomiting w/in 5mins of 2nd dose; w/in 24hrs devel wheezing, urticaria & swollen tongue;unprovoked bite by known rabid fox;bitten in lt heel
Fever; Body aches; Chills; Fatigue; This case was reported by a consumer via interactive digital media 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 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, general body pain, chills and fatigue. On an unknown date, the outcome of the fever, general body pain, chills and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the fever, general body pain, chills and fatigue to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient had experienced fever, body aches, chills and fatigue. The reporter wanted to know how long did these symptoms last.
felt down; redness on right arm and shoulder, redness on left arm and shoulder; itchiness on right arm and shoulder; Only first dose received; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (felt down) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history reported).    On 20-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced FALL (felt down) (seriousness criterion hospitalization). On 27-Feb-2021, the patient experienced ERYTHEMA (redness on right arm and shoulder, redness on left arm and shoulder) and PRURITUS (itchiness on right arm and shoulder). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Only first dose received). The patient was hospitalized on 21-Feb-2021 due to FALL. At the time of the report, FALL (felt down), ERYTHEMA (redness on right arm and shoulder, redness on left arm and shoulder), PRURITUS (itchiness on right arm and shoulder) and PRODUCT DOSE OMISSION ISSUE (Only first dose received) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      This report refers to a case of (Product dose omission issue) for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (fall, erythema, and pruritus), a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of (Product dose omission issue) for mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events (fall, erythema, and pruritus), a causal relationship cannot be excluded.