chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old patient received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Lot number: 9264), in left arm, on 02Mar2021 as dose 2, single (Lot number: En6202) and on 12Oct2021 as dose 3 (booster), single (Lot number: 30155ba) at the age of 81 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "apnea" (unspecified if ongoing); "obese" (unspecified if ongoing); "had tnductile cancer" (unspecified if ongoing), notes: had tnductile cancer w treatment through Nov 2021 through; "Sensitive to milk" (unspecified if ongoing); "gluten" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL AND HYDROCHLOROTHIAZIDE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Covid-19 treatment was done with paxlovir.  Clinical course : it was reported that on 07Jul2022, covid rebound 6 days after done with paxlovir.
stiffiness arm, legs, shoulders, neck; stiffiness arm, legs, shoulders, neck; stiffiness arm, legs, shoulders, neck; chills; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of MUSCULOSKELETAL STIFFNESS (stiffiness arm, legs, shoulders, neck), the second episode of MUSCULOSKELETAL STIFFNESS (stiffiness arm, legs, shoulders, neck), the third episode of MUSCULOSKELETAL STIFFNESS (stiffiness arm, legs, shoulders, neck) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     The patient's past medical history included Kidney stones, COVID-19 (Previous diagnosis of COVID-19.) and Hysterectomy (Uterus removed in 2020) in 2020. Concurrent medical conditions included Scar (Scar tissue from previous stone).    On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced the first episode of MUSCULOSKELETAL STIFFNESS (stiffiness arm, legs, shoulders, neck), the second episode of MUSCULOSKELETAL STIFFNESS (stiffiness arm, legs, shoulders, neck), the third episode of MUSCULOSKELETAL STIFFNESS (stiffiness arm, legs, shoulders, neck) and CHILLS (chills). At the time of the report, last episode of MUSCULOSKELETAL STIFFNESS (stiffiness arm, legs, shoulders, neck) and CHILLS (chills) outcome was unknown.        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.   No concomitant medications were provided. Treatment drugs reported included self administered pain relievers on 13-Apr-2021.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: NNI
I had a strong metallic taste in my mouth. The doctor said it could be thrush or an adverse reaction to the vaccine. I was prescribed an antifungal mouth rinse and after the 2nd day of user the taste was gone. I do believe I had thrush.
migraine - pain in right temple 2nd shot 3/17/09 did not get third shot
pt recv vax & 1 day post vax pt devel redness & swelling approx 12/inch below the HIB-TITER inj site;
Around 12 hours after the jab, I began experiencing side effects including fever, chills, & aching all over my body. These alone would not have scared me because I experienced similar side effects after my 2nd dose (which was Pfizer, by the way, as was my first dose). However, I experienced additional symptoms including an increased heart rate, chest tension, & reduced lung capacity, which combined to make me feel fatigued yet unable to sleep.  While the other side effects mostly subsided after 8 hours, these additional symptoms persisted. Around 22 hours after the jab, my resting heart rate was around 110 BPM, so I contacted a doctor through virtual urgent care, who told me that since I was experiencing no chest pain, there was no immediate cause for concern. He instructed me to stay hydrated and get examined in person if my symptoms remained after several hours. I waited about 3 hours and didn?t see much improvement, so I arranged to get examined in an emergency room around 29 hours after the jab. However, by that time, I noticed that my heart rate had decreased to around 100 BPM, which according to web search, is just within the normal range of human heartbeats. As such, I decided not to go. I stayed home, took some aspirin, and rested. Unfortunately, I had no appetite and ate nothing that day. I was able to sleep that night, though.  At 46 hours after the jab, my heart rate had further improved to just under 90 BPM. I continued resting and was able to eat a small meal. My condition continued to improve such that by the third day, I had sufficient appetite for two small meals. Five days later, I still have a reduced appetite, as well as some slight chest & lung tension. However, my resting heart rate is now under 80 BPM, which I believe is about normal for me.  In conclusion, the additional side effects initially scared me because they didn?t seem to get any better. Thankfully, my symptoms gradually abated over the course of 4-5 days. I am almost myself again!
This spontaneous report was received from a physician, via a company representative, referring to a patient (encounter key # 158394) of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-APR-2016, the patient was vaccinated with a dose of RECOMBIVAX HB, "10Pk 5mcg/0.5 mL SDLLokCap Ped", lot # L016959, expiration date: 12-MAR-2018, (dose number and route of administration were unknown), which was improperly stored. On unspecified dates, RECOMBIVAX HB had three temperature excursions of 0.55 Celsius degrees (33 Fahrenheit) for 96 hours, 1.11 Celsius degrees (34 Fahrenheit) for 528 hours and -0.55 Celsius degrees (31 Fahrenheit) for 72 hours, respectively. The vaccine status was reported as in excursion and the type of excursion and storage criteria were reported as refrigerator (R). No adverse effects were reported and no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Day of 2nd injection:  Beginning of some body aches  Day 2: Chills and mild fever, headache, and upset stomach Day 3: Excessive shaking and fever of 103, vomiting and headache; night sweats Day 4: Continued excessive shaking, fever above 100,  headache; night sweats Day 5: Fever above 100, headache, excessive night sweats requiring two changes of sheets and clothes; body soreness Day 6: Fever is 100.2, significant headache; no appetite, and continued body soreness
Day after immunizations, developed diffuse erythematous, fine macular rash of abdomen, legs, cheeks. No urticaria, no respiratory sx's. no v/d. No fever or irritability. Mon reports similar rcn with immunizations at 2 or 4 months. Also had given dose of TYLENOL.
Lymph nodes in armpits swollen to the size of a baseball; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Mar2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced lymph nodes in armpits swollen to the size of a baseball. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event lymph nodes in armpits swollen was not recovered at the time of this report.  No follow-up attempts are possible; information about lot number cannot be obtained.
1 week plus 1 day post vaccination my Left arm started to itch near the injection site and a red rash developed about 3 inch x 1 inch in size slightly below the actual injection point - it is still itchy and red  my face also feels slightly flushed on and off
red at near the injection site/red 3 inch wide; swollen; soreness; Itching around the arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching around the arm), VACCINATION SITE ERYTHEMA (red at near the injection site/red 3 inch wide), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PAIN (soreness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PRURITUS (Itching around the arm). On 19-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red at near the injection site/red 3 inch wide), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PAIN (soreness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 22-Jan-2021, PRURITUS (Itching around the arm), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PAIN (soreness) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (red at near the injection site/red 3 inch wide) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Woke up at 5AM with Throbbing  Headache and pain in left and right groin and hips. Took excredine , three hours later took 3 ibropene as I had to attend a funeral.  Later that day the groin pain, hip and leg pain returned on left side only. Next morning that pain was excruciating so I went to Urgent care and was prescribed Naproxen after  they X-rayed my hip., The Naproxen didn't work and I was unable to put any pressure on leg to walk. Still in the same severe pain I went to an orthopedic doctor. There they x-rayed my back and no fractures or causes for pain was discovered. I was prescribed Methylpredinisoleone 4mg dose pack.  Relief started apx 6 hours -8 hours after first dose.  Today, Nov 2, 2019, I only have slight pain.
Background: pharmacy received 49 vials of Pfizer COVID vaccine (Lot number EN6199) on 5 March 2021 and stored them in the pharmacy refrigerator.   The doses were labeled with an expiration date of 10 March 2021 at 0701.   Since starting the COVID-19 vaccine program, the pharmacy has always used the doses before they approached the expiration date.  This time, there were 16 vials of the Pfizer vaccine that had not been used and set to expire. The labeled expiration date and time were clearly present on the outside of the bag containing the doses.  On the morning of 10 March 2021, a pharmacist retrieved 1 vial at 0754 and 7 vials at 1138 from that allocation and provided them to nursing for the day?s administrations.  The pharmacy placed those doses in a new amber bag and did not label the bag with an expiration date and time.   The nursing team received the vials, diluted and drew up 20 doses that were administered to patients before 1230.    The charge nurse did not question the expiration date until after 20 patients had been vaccinated.  At that time she messaged the pharmacist to verify the expiration date.  The pharmacist indicated that the label did not state am or pm and misinterpreted the expiration time for the doses as 7:01 PM rather than 7:01 AM.  There was not a defined double check at the time of distribution from the pharmacy to nursing  The remaining 11 vials were quarantined.  The pharmacy manager contacted the manufacturer.  According to Pfizer it?s recommended to use the thawed vaccine within 120 hours, but can be used up to 144 hours.  The doses in question were administered before 125 hours after they were thawed.  The remaining expired vials will be wasted and appropriate notifications sent.  Assessment: Twenty patients received Pfizer COVID vaccine 5 hours passed the labeled expiration date and time.  While exceeding the manufacturer?s recommended beyond use dating, the doses were within the acceptable 144 hours post thaw period and still safe for patient administration.  There was misinterpretation of the labeled expiration time by the dispensing pharmacist, the container of COVID vaccine vials provided to nursing was not labeled with an expiration date or time, there was not a double check on hand off, the nursing team did not double check the expiration date/time before dilution or administration.  Recommendation:  When repackaging COVID Vaccine vials for distribution to vaccination centers, a label including the expiration date and time should be placed on the new container.    When COVID vaccine is transferred from one location or department to the next, a double check of the product, quantity, integrity and expiration date and time may prevent a recurrence of this situation.
Fever to 102F generalized tonic-clonic convulsion lasting approx. 30 seconds, minimal post-Ictal phase.
Received the Moderna COVID-19 vaccine and experienced atrial fibrillation; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Received the Moderna COVID-19 vaccine and experienced atrial fibrillation) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Received the Moderna COVID-19 vaccine and experienced atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Received the Moderna COVID-19 vaccine and experienced atrial fibrillation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment information was provided by the reporter.  Company Comment: This case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected serious event of atrial fibrillation. The event occurred on an unknown date with an unknown outcome. No further information was provided. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected serious event of atrial fibrillation. The event occurred on an unknown date with an unknown outcome. No further information was provided. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report
few hours after vaccine had headache, very mild sore arm that lasted an hour and red, itchy jaw, chin neck for a couple hours, The evening after the vaccine was given I had chills, sweats, body aches, fever of 100, the next morning headache, body aches all day and the 2nd day after vaccine I had chills, cold sweats (mainly at night ) but body aches all day, both days very tried and weak. Then after those two days i was back to normal. Same thing happened with my 2nd shot and same timing. i did have covid in the past in august 2020
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2016, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a healthcare provider for shingles in 2017. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue 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 include 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; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
12 cm hive and 25 cm erythema lasting 12 days required ice, NSAID's and antihistamines- did not see doctor as I am an MD.
The patient was normal when he went to bed at 9:30 PM. Awoke about 11:00 screaming, legs cramping, yelling it hurts, throat sore (could swallow liquid), could bend chin to chest. The fever and chills resolved by arrival to the ER, he was coherent, given instructions for croup all though not quiet, typical barking cough. seems fine in AM.
Itchy slightly raised rash around the injection site 9 days after injection. Also joint pain all over the day after the injection which resolved in a couple days.
A couple of days  not more than a week after the vaccine was administered I got  heart palpitations, heart racing, headaches and tiredness and very forgetful and did not feel l like myself.  I still have some of these symptoms but not as often.
Injection site redness and swelling beginning 3 days after vaccination. Still going on 8 days after vaccine.
Experienced lymph node sweeping under arm after vaccine. Have been experiencing lymph node swelling in neck and chest ever since, along with extreme fatigue. Have done bloodwork that has been inconclusive in determining the cause. Sent to specialist for further testing (appointment pending)
Immeditae headache, developed fever with chills/sweating, severe body aches, evolved into labored breathing. Presented to Clinic on 4/1/2021 for above symptoms.  Multiple tests performed. Negative for flu Awaiting results on COVID-19 test
This is a spontaneous report from a contactable consumer (reported himself). A 49-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8735), via an unspecified route of administration on an unknown date 2021 as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER8735), via an unspecified route of administration on 25Apr2021 as dose 1, single for covid-19 immunisation. Medical history included Known allergies, penicillin from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 30Jul2021, the patient experienced symptoms included mild/moderate fever, chills, body aches, fatigue, head cold-cough, moderate-elevated bp (blood pressure), high resting heart rate, anxiety, and mild loss of smell and taste. The patient was tested positive covid on 01Aug2021. The events resulted in emergency room/department or urgent care visit. On 30Jul2021, the patient lab test includes moderate-elevated blood pressure, high resting heart rate. On 01Aug2021, the patient lab test included post vaccination the patient was test for covid-19 with COVID test was positive (nasal swab). The patient did not receive any treatment for the events. The outcome of the events COVID-19, moderate-elevated bp, high resting heart rate, and anxiety was resolving.    Follow-up attempts are completed. No further information is expected.
They used this expired vial and administered 4 doses to 4 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They used this expired vial and administered 4 doses to 4 patients) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They used this expired vial and administered 4 doses to 4 patients).        For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Some side effects, diagnosed GBS; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-JAN-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Some side effects, diagnosed GBS) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-APR-2023 The reporter was the field representative. The reporter reported that the patient received first dose of Shingrix and noticed some side effects (unknown side effects) after the vaccination but did not report them. Upon returning to the clinic for her second vaccination, it was reported that the patient demonstrated symptoms of Guillain-Barre syndrome. The patient was hospitalized immediately (date was unknown). Upon hospitalization the diagnosis of Guillain-Barre syndrome was confirmed. No further information was known.  The reporter consented to follow up.