chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 14:00 as dose 4 (booster), single (Lot number: GJ3275) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Polymyalgia Rhuematica" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Lysinopril, reaction(s): "Allergy: Lysinopril". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Rebound after negative for 4 days; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received other medication in 2 weeks. Anti-viral details: Product: COVID 19 Treatment Paxlovid, Treatment start date on 17Nov2022 and stop date on 21Nov2022.  No follow-up attempts are possible. No further information is expected.
Leg weakness, head pain, ringing in ears, fatigue, lack of stability and general weakness. Did not get any treatment at Urgent Care, they did some test and said to go home and wait for the results. I rested for three consecutive days, hydrating, drinking water and liquids, I suspended all the prescribed medications for three days. Levothyroxine of 50mcg and Hydrochlorothiazide 12.5 after three days I started taking my medications again. After day three I recovered completely.
Caller states she received her second dose of Moderna on April 13, 2021 and to days later it became itch and red. She states that since then both s/sx have increased and the area is warmer compared to her other arm. Advised caller to call her PCP or urgent care to have the area assessed to r/o possibility of infection
patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.; patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021 at 2:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.) and POOR QUALITY PRODUCT ADMINISTERED (patients where administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 28-Mar-2021, Excursion time was 10 AM, temp was 35 , total doses given for the day was 150, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 3 vial was moved to clinic. Vaccine BUD date was 22-Apr-2021.  Vial was stored on cooler 1 , on 28-Mar-2021, Excursion duration At 9 AM: 43, 10 AM: 38, 11 AM:35, 12 AM:44, 1PM : 41, 2 PM : 36, 3 PM: 46, 4 PM: 46 and 5 PM : 42.  Vials only punctured right before administration  Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    Treatment medications were not reported.
Diff. swallowing, hives, rash ? allergic reaction app 24 hrs after rec. tetanus shot.
Quadracel was given to 17th month old who was behind on shots. There was no known reaction.
All of the vaccine leaked at the time of administration due to faulty syringe.  Patient was appropriately re vaccinated per guidelines.
pt says received vaccine on 5/1 and had a stroke ion 5/7     Dr said could have come from vaccine  but unsure      Told pt to receive second dose and had no issues      Notified rph today and says she is ok
mom states that starting approx 30hr p/vax pt started crying inconsolably for 9PM till 3AM;
Information has been received from a certified medical assistant concerning an actually 16 year old female patient who on 2009 (dates unknown) was vaccinated with the first and second dose of GARDASIL (Lot numbers not reported). The medical assistant reported that the patient experienced flu like symptoms after the first and second dose of GARDASIL vaccine. Both doses were given on time in 2009. The patient would be getting the third dose late and it would be given today. The patient sought medical attention by speaking with the physician. At the time of the report, patient had recovered from flu like symptoms. Additional information has been requested.
Very swollen, inflamed red left upper arm deltoid area-advised ice (intermittent), children's Motrin for anti inflammatory, Cortaid for itching (topical) or Benadryl.
I haven't used my inhaler for asthma about 2 to almost 3 years and now I'm using my inhaler everyday a few times a day constantly having asthma attacks after my second dose of the vaccine
Patient experienced a bilateral rash on her legs and arms following vaccination. Began about 1 hour after administration, lasted roughly 1 week. It was her first dose of Shingrix.
Three days post-vax the patient began crying 2-3 hours and could not be consoled. A fine nonpuritic rash developed on his chest, mouth and legs at the injection sites. The patient has been vomiting large amounts of formula for 4-5 days. Mother denies fever and antibiotic therapy recently.
Achy all over in all joints, to severe pain. Shot given at Clinic on 12/17/2004.
She stated that she was experiencing full body excruciating pain and high fever. She described the pain as being more painful than giving birth.
Between my first COVID-10 vaccine and my second vaccine I had experienced heart pain. I was concerned because heart inflammation was a side effect from the J&J vaccine. I saw my doctor and we spoke about potential inflammation I was erring on the side of caution to rule out any potential contributing factors that may had led me to believe the same side effect could happen with other vaccines. But because data was new as well as the vaccinations I could not make this determination 100%. My family doctor prescribed a 14- day regimen, of which I could only get through approximately 5 to 7 days. I don't even think I took six pills (but I am missing 2). I felt immediately pained on about the second day of taking it. As the days passed I had a more intensified pain. I began to experience emergency-like symptoms, which placed me in a state of panic. My best bet was to seize taking it all together. By that point I had my 2 doses of the Pfizer COVID-19 vaccination. So in short and despite feeling straight COVID-related status symptoms, it took time for the medication to leave my body. It was not hard for me to determine how my body was feeling in regard to either the medication or the vaccination. I knew exactly what bodily sensation was causing what pain because I was hit fast with the medication symptom and already a week in. A lesson learned and more work to be done.
Pain, 6 hours after vaccine Sore breasts, 11.5 hours after vaccine Swollen lymph nodes under left armpit and in neck, 21.5 hours after vaccine  Brain fog, 21.5 hours after vaccine Tiredness, 21.5 hours after vaccine
A non-serious spontaneous report of administration to a 22-month-old was received from a health professional concerning a 22-month-old male. Neither the patient's past medical history nor the concomitant medications were reported. On 29-Aug-2011, the nurse inadvertently administered FLUMIST to a 22-month-old male. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 14-Sep-2011: No adverse events occurred subsequent to receiving FLUMIST.
Reactions to the second shot started with my eyes feeling weird and sensitive to light. Pupils were dilated at different sizes.  Approx. a week later my right side felt weird, heavy and I had high anxiety, thought I was having a stroke. I than developed extreme dizziness, sweaty palms and was very nauseous. These symptoms passed (not my eyes, that is a constant) and I developed other symptoms over the next few months. Achy legs, left big toe numb, shaky hand, brain fog, dissociation along with suicidal thoughts and extreme pins and needles over my whole body. Tons of eye floaters, tinnitus, electrical shocks, pain under my arms (swollen  lymph nodes), internal shaking, terrible ear pressure, head feels like it's underwater and under pressure, pressure across my cheeks and nose, insomnia. My symptoms come and go and some days are better than others. Not all symptoms last (thanks god!) This is VERY scary. I am trying to get answers, but really need the medical community to step up and help those that have had AE!
Walking my dogs with my girlfriend 08-02-21, walked less than a mile, started to lose track of things, Ex: did I really just take a step/did not know where I was, girlfriend told me that I started having a grand mal seizure while standing up, eyes rolled back, extreme shaking from head to toe, stiffening of all extremities, fell to the ground she caught my fall (head), continued to seize for less than 2 minutes, passed out and stopped breathing, skin color went from white to grey (less than 10 sec), temp paralysis and memory loss, did not know who she was or remember anything until I was at the hospital, by ambulance, bloodsugar, vitals,  CT, EEG all normal, I know 3 other people with same story.
This spontaneous report was received from the registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with RECOMBIVAX HB (dose, route and lot were not reported). On an unknown date, the patients received improperly stored RECOMBIVAX HB.  No adverse symptoms reported. At the time of the report the action taken was not reported.  All telephone attempts to obtain follow-up information have been unsuccessful.   Follow up information was provided by the register nurse refers to a 1 day female patient. Current conditions and concomitant medications were not reported. On 18-JUN-2014 at 20:47, the patient was vaccinated with an improperly the first dose of RECOMBIVAX HB (Thimerosal Free) intramuscular, lot number J012520 and expiry date 30-JAN-2016). On 09-JUL-2014 at 10:58 AM, the patient received the RECOMBIVAX HB stored to 0-1 degree of temperature x18 different episodes, according to minimum/maximum. All recorded temperature were within 2-8 degrees. The issue that occurred was that they had a temp of 0-1 degrees on 18 different episodes between May 14th and July 21st, they were not able to identify how long the temps were down because it was not documented accordantly. They knew that when the temps were checked each AM and each PM they were within the normal 2-8 degrees. The vaccine was removed once problem was  identified and was not been used after 21-JUL-2014. This is one of several reports received from the same reporter. Additional information is not expected because all follow up information was received.
Pt called insisting that he had reaction to flu vaccine. Sx include nausea starting in evening and con't throughout the night. Improved somewhat by am of 11/07/2002
Parkinson's got worse; blood pressure went high; A spontaneous report was received from a consumer concerning a 76 years old, female patient who developed worsened Parkinson's Disease and increase blood pressure.  The patient's medical history included surgery to remove bowel obstruction and Parkinson's Disease. Concomitant product use was not provided by the reporter.  On 5 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch number: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.    On 5 Feb 2021 the patient's blood pressure went high and Parkinson's got worse. Treatment for the events was not provided.   Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, Parkinson's got worse and blood pressure went high, was unknown/ not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
11 Hours after injection had 102 degree fever and chills, Slightly sore arm, swollen lymph nodes in left armpit and left side of neck for 3 days. Swollen lymph nodes near left collar bone for 5 weeks. It was the size of a large pea. Developed an asthmatic cough and allergies heightened with nasal drip and itchy eyes.
Received vaccine at 1 PM. At 2:30 AM pt awakened with dry mouth, shaking, and "jerking". Was advised to go to ER wherein the physician drew lab work and stated her symptoms were related to her receiving the vaccine. Symptoms resolved spontaneously.
Pt reports 9 days post vaccine he had insomnia, irritability, local inflammation 3-4", malaise, nausea.
Patient was administered a dose of the Moderna COVID from a pre drawn syringe stored at room temperature for 23 hours; ts that the third dose was given from a pre drawn syringe which had been stored at room temperature for longer than; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Patient was administered a dose of the Moderna COVID from a pre drawn syringe stored at room temperature for 23 hours) and EXPIRED PRODUCT ADMINISTERED (ts that the third dose was given from a pre drawn syringe which had been stored at room temperature for longer than) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient was administered a dose of the Moderna COVID from a pre drawn syringe stored at room temperature for 23 hours) and EXPIRED PRODUCT ADMINISTERED (ts that the third dose was given from a pre drawn syringe which had been stored at room temperature for longer than). At the time of the report, PRODUCT STORAGE ERROR (Patient was administered a dose of the Moderna COVID from a pre drawn syringe stored at room temperature for 23 hours) and EXPIRED PRODUCT ADMINISTERED (ts that the third dose was given from a pre drawn syringe which had been stored at room temperature for longer than) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications includes Acuvar Readihaler, Vitamin D, Multivitamin   Treatment medications was not provided.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot # L046508, expiry date 17-MAY-2017, lot # M007964, expiry date 15-AUG-2017 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects were reported. Administered vaccines underwent a temperature excursion of 5 to 14 degrees Fahrenheit for 2 hours and 5 to 14 degrees Fahrenheit for 5 hours 10 minutes. This is one of several cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA002418: US-009507513-1701USA007865.
renal injury and cardiac arrythmia; renal injury and cardiac arrythmia; This serious case was reported by a physician via call center representative and described the occurrence of renal injury in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Boostrix and Shingrix. On an unknown date, an unknown time after receiving Boostrix and Shingrix, the patient experienced renal injury (Verbatim: renal injury and cardiac arrythmia) (serious criteria GSK medically significant) and cardiac arrhythmia (Verbatim: renal injury and cardiac arrythmia) (serious criteria GSK medically significant).  The outcome of the renal injury and cardiac arrhythmia were unknown.   It was unknown if the reporter considered the renal injury and cardiac arrhythmia to be related to Boostrix and Shingrix.     It was unknown if the company considered the renal injury and cardiac arrhythmia to be related to Boostrix and Shingrix.   Additional Information: GSK Receipt Date: 21-AUG-2023 The physician was trying to find causality between Shingrix and Boostrix for renal injury and cardiac arrhythmia. Physician was not sure what caused the renal injury and cardiac arrhythmia. The follow-up could not be possible as no contact details were available.
Approximately 1-2 days after receiving the vaccines listed in #13 and having a PPD test, patient developed delayed onset angioedema manifested by swelling of the tongue. She had no other symptoms. She was seen by her local civilian MD; no treatment was given, but patient was instructed not to take the yellow fever and typhoid vaccines together. Since then, she has received tetanus, Hep A, and had PPD without problems. She has not had the yellow fever vaccine. She will be having a controlled dose typhoid challenge on 5/5/03.
NO ADVERSE REACTION NOTED. PT CLAINS HE HAS NOT RECEIVED HIS 5TH BOOSTER DOSE OF BIVALENT COVID-19 BOOSTER. PT ASKED TO BE SCHEDULED TODAY 11/17/2022 TO GET THE BOOSTER DOSE. WHEN PT HANDED HIS COVID-19 VACCINATION RECORD CARD, THERE IS A RECORD OF MODERNA BIVALENT 010H22A GIVEN ELSEWHERE.
PER ER REPORT: HURST LEFT JAW TO OPEN MOUTH, SHOOTING PAIN TO LEFT SIDE OF HEAD, JAW SWOLLEN, SORE THROAT, DIZZINESS TREATMENT: PT TOOK BENADRYL; ER ADMINISTERED PREDNISONE
C/o restlessness & irritability /w low grade T(99.8/R) same day imm given. States began inconsolable high pitched crying 7 am on 1Mar91. Had 4 episodes ea one /w 1-2 hrs duration.Has one occurred 6 pm on 3Mar91.States today infant fine.
redness; itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PRURITUS (itching) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history per source document.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PRURITUS (itching). At the time of the report, VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PRURITUS (itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Left side of pelvis, pubic area, thigh hip, back of hip and small of back all ached; also constipated; abdominal cramps on left side; joint stiffness on left side and both hips; some blisters in these areas.
Evening after vaccinations infant lethargic, would not make eye contact or vocalizations as per normal. Phone call to physician - instructed to watch. Infant continued to be less responsive, decreased vocalizations, no eye contact, physician evaluation 8-6-12, change in status per parent continued for several days did not begin to babble or coo again until 9 1/2 months.