chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed Practical Nurse, refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. on unknown dates, the patients were vaccinated with a dose of VARIVAX (lot# L031068, expiration date 18-AUG-2017). The vaccines were exposed to a temperature of 17 Fahrenheit (F) for 55 hours. Digital data logger was involved. There was no previous temperature excursions. Product quality complaint (PQC) was not reported. No adverse effects were reported. A call was placed to the nurse that requested patient identifies, lot number, expiration date and date of vaccination. This is one of two reports received from the same reporter. Additional information has been requested.
got her first Shingrix vaccine in 2019 but not the second one due to the pandemic; This case was reported by a consumer and described the occurrence of social problem in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, did not receive 2nd dose of Shingrix due to pandemic, which led to social problem. The reporter did not consent to follow up.
received the adjuvant only; received the adjuvant only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number XG52X, expiry date 28th November 2021) for prophylaxis.   On 18th June 2021, the patient received the 1st dose of Shingrix. On 18th June 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received only adjuvant during the day and then completed reconstitution of vaccine after that ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered  The reporter consented to follow up.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the only adjuvant only of Shingrix during the day, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient was given complete reconstituted vaccine after that. The reporter consented to follow up.
Lightheaded, flushed/sweating. Offered water and juice. BPs 96/63 (pulse 70), 102/65 (pulse 68).
As with every vaccine and booster I have received (total of 5 doses), I developed a severe fever blister on my lip within 3 weeks of having the injection.  Prior to receiving these vaccines, I rarely experienced these outbreaks.  I have reported each outbreak I have experienced through VAERS.  Over the past 8 mnths, I have taken valacyclovir to limit the number of blisters.  Unfortunately, I stopped taking the medication 2 months ago.  After the fever blister formed yesterday, I began taking 500 mg valacyclovir again to lessen the severity.
Expired MMR vaccine given in left lower thigh at approx. 11:00am 5/12/2008.
3 days after vaccine, developed fever 102 degrees, chills, palpitations, severe myalgias on right side and right shoulder (injection site), right hip and knee, chest pain and dyspnea.
Psoriatic arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4303430-00.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1157581) at citrate free for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1, Route of Admin: Intramuscular), administration date: 01Apr2021, when the patient was 52 years old, for COVID-19 Vaccination; Bnt162b2 (DOSE: 2, Route of Admin: Intramuscular), administration date: 01May2021, when the patient was 52 years old, for COVID-19 Vaccination. The following information was reported: PSORIATIC ARTHROPATHY (medically significant) with onset Feb2022, outcome "recovering", described as "Psoriatic arthritis flare up". The action taken for adalimumab was unknown.  The reporter considered "psoriatic arthritis flare up" related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Psoriatic arthropathy  which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness in the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 MYALGIA (soreness in the arm). At the time of the report, MYALGIA (soreness in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Tingling and numbness in legs and feet 2 days after 1st dose and 30 minutes after second dose. The feeling has been ongoing since my first dose.
12/19/20 Employee's written report/description of events: shoulder injection site, left shoulder. Including shooting pain from my left wrist into the left side of my face. I have shooting pain into my chest from the injection site which also has included involuntary muscle movement in my neck and face, involuntary muscle movement is painful and this occurs with dizziness. All the pain stems from the injection site itself and always starts there when the pain happens.  12/23/20 saw OHS RN and was improved: states symptoms are better today & no involuntary muscle movements experienced today.  Pain at injection site is less also.  Has been using OTC Aleve, 1-2 every 12 hours.  CMS left hand intact; all digits both hands have pale nail beds with > 2 sec cap refill; skin temp cool to warm.  States has been on a medication that can cause Reynaud's disease; and has been concerned this may be occurring.   Work comp MD appt. for 12/30/20; has not confirmed.
my arm became hot to touch at the injection site; my arm became red at the injection site; my arm became itchy at the injection site; a rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (my arm became hot to touch at the injection site), VACCINATION SITE RASH (a rash at the injection site), VACCINATION SITE ERYTHEMA (my arm became red at the injection site) and VACCINATION SITE PRURITUS (my arm became itchy at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Heart disorder.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE RASH (a rash at the injection site). On 03-Mar-2021, the patient experienced VACCINATION SITE WARMTH (my arm became hot to touch at the injection site), VACCINATION SITE ERYTHEMA (my arm became red at the injection site) and VACCINATION SITE PRURITUS (my arm became itchy at the injection site). At the time of the report, VACCINATION SITE WARMTH (my arm became hot to touch at the injection site), VACCINATION SITE RASH (a rash at the injection site), VACCINATION SITE ERYTHEMA (my arm became red at the injection site) and VACCINATION SITE PRURITUS (my arm became itchy at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient used Ice packs for treatment.
painful at the injection site; sore throat; stuffy nose; tired; arm felt like was sleep, numb/cannot feel my finger; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (arm felt like was sleep, numb/cannot feel my finger), VACCINATION SITE PAIN (painful at the injection site), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (stuffy nose) and FATIGUE (tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 037A21B) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included LANSOPRAZOLE (PREVACID), PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) 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 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced HYPOAESTHESIA (arm felt like was sleep, numb/cannot feel my finger). On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (painful at the injection site), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (stuffy nose) and FATIGUE (tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (arm felt like was sleep, numb/cannot feel my finger), VACCINATION SITE PAIN (painful at the injection site), OROPHARYNGEAL PAIN (sore throat), NASAL CONGESTION (stuffy nose) and FATIGUE (tired) outcome was unknown. Not Provided
The pt has a problem with chronic otitis media, speech problems for unknown reasons, vision and hearing adequate. Child had elevated temp, and many hours of high pitched crying after receiving his first set of immunizations on 10/10/1992. After the initial immunizations the child was given Benadryl prior to and for 24 hours after administration of vaccine.
Uncontrollable vomitting on the way to school, extreme fatigue after, slept for 10 days with no energy.
Patient received injection, then went to wait in another chair about 10 feet away for the 15 minutes afterwards.  Within 2 minutes, she went back to the vaccination chair, and said she was going to be sick. She was bent over her knees, sitting in a chair, and leaning over the garbage can. She was extremely hot and sweaty by this time, and dry-heaving and spitting into the garbage.  I put a cool, wet paper towel on her forehead, and fanned her back with a plastic sheet.  She leaned back in the chair, and got very dizzy. I had to hold her in place, and she was about to lose consciousness, but she snapped out of it.  I had my technician call 911 at this point.  They came in 15 minutes. By this time, patient's temperature had returned to normal, except now, she was wet from sweating, and shaking from freezing in the AC.  The medics checked her vitals and said they were normal. The patient opted to get a ride home from a family member, and opted not to go to the hospital.  I tried to contact her today to see how she was doing, but was unable to reach her.
Swelling in the neck started a few days after receiving the first dose of the Covid vaccine.  Its not known if the swelling is related to the vaccine.  Medical exam by primary said my thyroid is a bit full.  Some post nasal drip as well.  Discomfort from the swelling became gradually more significant over several days.  Some tightness when swallowing food.   At this time of year I typically get allergy symptoms of hay fever (sneezing, itch/watery eyes, etc.) but neck swelling has never been a symptom for me.  Started taking Claritin once a day as I usually do this time of year as well.
Stage 1 Cancer; First Novavax booster; 3 Pfizer doses before that; First Novavax booster; 3 Pfizer doses before that; This serious, initial spontaneous safety report from the was received by Novavax on 09-MAY-2023 from a consumer via the contact center.  A 81-year-old female was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine dose 4 (reported as second booster) in the left arm on an unspecified day in SEP-2022.  Medical history included vaccination with dose 1, dose 2, and dose 3 (reported as first booster) of Pfizer BioNTech COVID-19 vaccine (tozinameran) in the left arm on unspecified dates. The individual had no illnesses at the time of vaccination, no allergies, and had never tested positive for COVID-19.  Concomitant medications included turmeric supplements, calcium, and vitamin D.  On an unspecified day in SEP-2022, the individual received her first Novavax booster after 3 doses of Pfizer (PT: COVID-19 immunisation) (PT: Off label use). On an unspecified day in APR-2023, after vaccination, she was diagnosed with stage 1 cancer (PT: Neoplasm malignant) (Serious: Medically Significant). The individual stated she would become immunocompromised after she would soon begin chemotherapy treatment.  On an unspecified day in SEP-2022, the event outcomes of COVID-19 immunisation and Off label use were recovered/resolved. At the time of reporting, the event outcome of Neoplasm malignant was not recovered/not resolved.  Lot number was requested but was unknown to the reporter. Sender's Comments: This 81-year-old female experienced: Neoplasm malignant, COVID-19 immunisation and Off label use after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Neoplasm malignant was reported as serious. The events COVID-19 immunisation and Off label use were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
Injection area on right arm became very red, inflamed, hot and had raised bumps. Area on my arm was about the size of a baseball. Lasted 2 days. No other symptoms
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2007, the ZOSTAVAX was administered to the patient (lot number, dosage and route of administration not provided). On or about 2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Patient was seated in observation area, after 10 minutes she became lightheaded and felt like she was going to faint, observation RN helped CG to put her head down between her knees, symptoms resolved quickly and increased HR came down from 100 to 80, BP down from 140/80 to 110/62.
I just realized that I was able to report the reaction I had. After the injection, I had a headache that lasted through the night. I woke up the next morning feeling like I had the flu. My body was achy, I was dizzy, and I had chills. No fever. This lasted for 4 days. I was very exhausted. My left arm at injection site swelled up very large and red for 4-5 days. I felt awful after that vaccine. I just wrote it off as an effect of the shot. I am still having problems with occasional dizziness, fatigue and dry eyes. (unsure if it is related)
SOB, red eyes. SOLU-MEDROL 125mg inj/BENADRYL 50mg inj.
Client states 1 1/2 hours, post vax, her left knee began throbbing and twitching and has continued. States now her right knee is painful but no twitching. Denies any numbness or weakness. States left shoulder is painful this morning, 2/8/00. She is complaining of slight headache on and off and plans to see husband's MD on 2/9/00, no PMD herself.
On 8/29/00, the pt developed red papular rash. Seen in office on 8/30/00. No fever, vomiting, or diarrhea.
The morning after the vaccine I started getting chills, fatigue and a headache (which I was pretty much expecting) but then in the afternoon I was converting face to face appointments to telephone appointments, and suddenly I couldn't remember how to do it.  It took about 15 minutes to do the first one (which I can usually do in 2 - 3 minutes) and about that long to do the next one.  After that, it came back to me, but it was a bit scary.
Bubbles of water pumping up in the hands and body; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Bubbles of water pumping up in the hands and body) in a 39-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 03-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLISTER (Bubbles of water pumping up in the hands and body). At the time of the report, BLISTER (Bubbles of water pumping up in the hands and body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Loss of consciousness; Dizziness; Hyperhidrosis; Hypoaesthesia; Pallor; This case was received FDA VAERS (Reference number: 1086426) on 18-May-2021 and was forwarded to Moderna on 18-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema. Concurrent medical conditions included Skin infection (Infection on mid to lower back, possible eczema per patient). Concomitant products included TRIAMCINOLONE for Eczema, CEPHALEXIN [CEFALEXIN] for Skin infection.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), HYPOAESTHESIA (Hypoaesthesia) and PALLOR (Pallor). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), DIZZINESS (Dizziness), HYPERHIDROSIS (Hyperhidrosis), HYPOAESTHESIA (Hypoaesthesia) and PALLOR (Pallor) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Oxygen saturation: 99 (normal) 99.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter states that the patient received shot and then blacked out a minute or two later. The reporter called 911, and while on the phone the patient regained consciousness and felt much better.  EMS checked him out and all of his vitals were normal and he could walk upright just fine.  Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded, although the events may be associated with the act of being injected rather than with the vaccine itself.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded, although the events may be associated with the act of being injected rather than with the vaccine itself
First vaccination 5-7-2021 resulted in approximately 5 days of flu-like symptoms.  Fatigue, constant fever (100), chills and achy joints.  Second vaccination 6-4-2021 resulted in approximately 2 days of flu like symptoms.  Similar to first vaccination.  Additional effect included alteration of smell and taste.  Many things such as meat (chicken, beef, pork), garlic, ginger, coffee has a similar foul odor and taste.  Even gasoline fumes at the gas station have the same foul odor as coffee brewing in my kitchen.  This secondary effect has remained since the second vaccination and shows no sign of stopping.  Some food that is edible includes pasta, rice, bread.  Limited seasoning such as salt, pepper, butter and red pepper flake.  As a whole the dairy family seems to be ok.  Milk, butter, ice cream, cheese, etc.  It seems the most prolific or prominent smelling and tasting things have the same foul pungent odor and taste.  One common bad taste.  Not different bad tastes for different foods.
Given vaccines at 20 month WCC on 4/8/10 - MMR #1, Varicella #1, Hepatitis A #1. Had several chicken pox-like lesions the next day with low grade fever, some vomiting/diarrhea. These symptoms resolved in 2-3 days followed by classic hives for 2-3 weeks.
5 hours after painful swelling upper arm and transient loss of sensation in fingers: recovered in 72 hours.
Dose administered too soon Narrative: prior to vaccine administration, vaccinator could have reviewed date first dose of vaccine was administered on vaccine record card or computerized patient record and confirmed that it had been at least 17 days since dose received.
Swelling and redness appeared two days after vaccination around injection site area. Red patch was about the size of a baseball. Patient reporting itching and burning. I recommended BENADRYL and Ibuprofen.
pt recvd vax & had sore arm,hard; red; swollen hot & approx 6 X 2; seen by MD;