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) from product quality group. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8737), in right arm and on 25Apr2021 as dose 2, single (Lot number: EW071) at the age of 64 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Nov2021 as dose 3 (booster), single (Lot number: 067F21A), in right arm and on 07Apr2022 at 12:00 as dose 4 (booster), single (Lot number: 027L21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Product investigation summary concluded the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8737 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot ER8737, fill lot EW3426, and the formulated drug product lot EP8586. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are needed. No further information is expected.
Case number PHEH2015US000669 is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 76-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145205) intramuscularly at a dose of 0.5 ml on 21 Oct 2014. The pharmacist reported that FLUVIRIN reached below 36 F for 3.5 non-consecutive days and 33.1 F for less than 12 hours. The pharmacist did not believe that the vaccine was frozen instead thought it was thermometer malfunction. No adverse event was reported following the maladministration. No further information was provided.
Vial refrigerated on 18-Nov-2021 after expiry; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated on 18-Nov-2021 after expiry) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 06-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial refrigerated on 18-Nov-2021 after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial refrigerated on 18-Nov-2021 after expiry) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No temperature excursion happened after vial was placed in refrigerator on 18-Nov-2021.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.  No adverse event was reported.
Patient answered "no" on could you be or possibly be pregnant questionnaire prior to receiving vaccines.  Patient contacted Immunizations department this afternoon after taking a home pregnancy test which tested positive.  Patient
COVID POSITIVE Narrative:  COVID infection following completion of COVID vaccine series 01/16 COVID vaccine dose #1 02/18 COVID test negative (tested due to travel out of country for work) 03/09 COVID vaccine dose #2, COVID test negative 03/25 COVID test POSITIVE, no symptoms 04/07 COVID test negative, never had symptoms
He broke out in a red itchy rash. He was treated with Dytan, Orapred and Aclovate. The next day the pt came in the symptoms were resolved.
pt came back after receiving both vaccines stating she is feeling weird.  She has a history of serious allergic reaction to red dye but not the flu shot or the first two covid doses of pfizer.  She started feeling flush, nauseous, itchy and then developed swelling in neck.  Pt was given 150 mg of liquid benadryl and we started her breathing treatment with albuterol.  EMS was called and 1 dose of 0.3 epinpen was given in right thigh.  Pt reported the need of a second dose which was given in the left thigh 15 minutes later.  EMS arrived and pt was passed off and taken to local hospital.
patients following 6 months after receiving the vaccine "don't have antibodies"; 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 DRUG INEFFECTIVE (patients following 6 months after receiving the vaccine "don't have antibodies") 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 DRUG INEFFECTIVE (patients following 6 months after receiving the vaccine "don't have antibodies"). At the time of the report, DRUG INEFFECTIVE (patients following 6 months after receiving the vaccine "don't have antibodies") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not reported.  Treatment information was not reported.
This spontaneous report was received from a licensed vocational nurse and refers to 2 unspecified patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date in November 2015, the patient was vaccinated with a dose of an improperly stored PROQUAD, lot number L011080, expiration date 01-OCT-2016, (dose and route were not reported). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was reported. This is one of several reports from the same reporter link. Additional information has been requested.
Constant, sharp, non-radiating left mid abd pain - onset approx 24 hour after 1st oral typhoid, negative for N,V,D,C ? fever. 2nd dose taken 01/03/05- pain cresenoed 01/04/05 and decrease but not resolved 01/06/05 after 3rd dose 01/05/05.
Moderna COVID-19 Vaccine EUA - Dizzy, cold sweating, rapid heart beat, soreness.  One week later swelling at injection site with red oval (6 inches by 4 inches) with redish and white color and bumps. Under arm of same arm injection site swelling in arm pit area.
Bruise, redness, swelling at vax site. Temp 101, inconsolable crying, cough, runny nose, irritability, vomitting due to crying. Lesser appetite. Referred to ER if signs of unconsciousness. Recommend Tylenol every 4 hrs.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 01-MAR-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength 0.5 mL, lot # L027282, expiration date 21-SEP-2017, dose and route were unknown). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion six times. The total cumulative excursion time (Hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first excursion was 56, 33 and R. The total cumulative time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 120, 29 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the third excursion was 24, 49 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the fourth excursion was 24, 48 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the fifth excursion was 24, 31 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the sixth excursion was 48, 34 and R. This is one of several reports received from the same source. Additional information has been requested.
Patient had sudden warmth, tingling in upper extremities, numbness and tachycardia along with hypertension
This spontaneous report was received from a physician via company representatives and from a support services director, referring to a patient of unknown age and gender (encounter key# 365729). The patient's concurrent conditions and medical history were not reported. There were no concomitant medications provided. On 14-MAY-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "PFS 6x1 10mg/1 ml w/o SftySyr" (dose, dose number, route and anatomical location were not reported) lot # J010164 and expiration date 14-FEB-2016. On an unspecified date, RECOMBIVAX HB had one temperature excursion of 2520 hours. The lowest recorded temperature was 20 degrees Fahrenheit (-6.666666667 degrees Celsius). No adverse effects reported. No product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "Refrigerator (R)". This is one of several reports received from the same reporter. Additional information has been requested.
I administered 1 ml, the correct dose is 0.5 ml.  Patient has no adverse event.
Patient was administered a vaccine from the primary Moderna series rather than the bivalent vial. Notified patient of error. Patient denied experiencing adverse effects after vaccine administration and is currently doing well. He will notify this provider if any issues arise later.
I had dizzy spell on the 18th from afternoon to the late evening and was unable to walk by myself. I thought I was dehydrated so I had water and ate. On the 20th it happened again. After that I was fine for the rest of the week. The following week I started getting a pain in my neck on the right side that got more and more painful and became bilateral. I decided to call the Dr. I saw him on 9/30, the doctor sent me for a brain scan  because he felt my facial features were off when I smiled. I saw my RA doctor and they confirmed it wasn't a flare up of RA. I was prescribed pain medications and physical therapy.
My left hip and front upper thigh is numb almost to the pubic area in the front.I have never had this happen to me prior to the vaccine, but it does seem to be an odd side effect.
Vaccine not viable, Out of temperature range,  No adverse reaction,  Will revaccinate.
mom reports fever of 104; describes pt as fussy & red, sore leg; states fever persisted x 3 days; did not use APAP becuase didn't want to mask sx;
Vial was punctured for over two weeks; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) after the vial was punctured for over two weeks.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received the second of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.   On the unknown date, the vaccine administration facility had administered the second dose of the Moderna COVID-19 vaccine to the patient. After they administered the dose, the facility realized that the same COVID-19 vaccine vial had not been properly stored or disposed of after it was previously punctured. The vial had been expired for about 2 weeks. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event was not applicable.   The event, vial was punctured for over two weeks, was considered resolved.; Reporter's Comments: This case concerns a patient who received the second of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection and vial was punctured for over two weeks. There were no reported adverse events after the vaccine was administered associated with the event of out of specification product use.
Weak, sick, nausea, fatigue, vertigo, and eruptions of yellow, itchy papules, rash on right shoulder.
tongue was sore; red dots; sometimes it's burning; This spontaneous case was reported by a consumer and describes the occurrence of GLOSSODYNIA (tongue was sore), TONGUE ERYTHEMA (red dots) and GLOSSITIS (sometimes it's burning) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GLOSSODYNIA (tongue was sore), TONGUE ERYTHEMA (red dots) and GLOSSITIS (sometimes it's burning). At the time of the report, GLOSSODYNIA (tongue was sore), TONGUE ERYTHEMA (red dots) and GLOSSITIS (sometimes it's burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used mouthwash to treat his symptoms. patient suspects it is Plica Fambriata. Patient has underlying condition which he does not want to mention.
Mother reported that patient developed rash after getting the vaccine. Patient presented red, round patch under left arm and pink color bumps on upper back and torso. Mother said that patient has sensitive skin but rash looked new to her.  Asked mother to stay for 30 minutes to observe the patient. Patient's bp 100/62 R48 HR 88 at 11: 02 am. After 30 minutes patient's skin rash had dissipated and bp was 86/60 R36 HR 36 at 11:32 am. Medical director has been informed and mother indicates that she feels comfortable leaving the facility and states that she understands that if conditions worsens to go directly to the hospital.
Unidentified patient experienced swollen arm after receiving the Moderna vaccine.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (Unidentified patient experienced swollen arm after receiving the Moderna vaccine.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    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 PERIPHERAL SWELLING (Unidentified patient experienced swollen arm after receiving the Moderna vaccine.). At the time of the report, PERIPHERAL SWELLING (Unidentified patient experienced swollen arm after receiving the Moderna vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Pt recvd 3 doses of Hep B vax on 19JUN90, 07JUL90 & 19DEC90; On 14JAN91, lab eval revealed pos titers for HTLV I & HTLV 2; No further details were provided;
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patients' concomitant medications, concurrent conditions, pertinent medical histories, drug reactions or allergies were not provided. On an unknown date, the patient may have received an improperly stored dose of either VARIVAX lot # M005971, expiration date 02-FEB-2018 or ZOSTAVAX lot # M041510, expiration date 27-JUL-2017 for prophylaxis (dose not reported). The administered dose of vaccine were reconstituted with sterile diluent (lot # and expiration date were reported as unknown). The medical assistant was not sure which vaccine the patient may have received. The dose was stored at temperatures in the range of 6 degrees Fahrenheit to 14 degrees Fahrenheit for a total time frame of 8 hours as identified by a digital data logger. It was reported that there were no previous temperature excursions. No adverse effects were reported. No additional information was provided. Additional information has been requested.
Information has been received from a physician concerning a 2 year old male whose brother was vaccinated with a first oral dose of Rotateq. Five days later the 2 year old got a severe chest of Rotateq. The 2 year old was taken to the hospital where he was tested for Rotateq, which came back positive, it was not indicated if the patient was admitted to the hospital. The patient was treated for dehydration. It was reported that the patient's brother was vaccinated with a second oral dose of Rotateq, and 5 days after the brother developed what the physician believed to be rotavirus antigen. At that time the patient was not tested for rotavirus. It was noted that the patient's mother was concerned if she should have the younger child get the third dose of Rotateq. It was also noted that the children had little contact with other children. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Within 24 hours of having the Booster I became bedridden with a fever, headache, and electrical shocks running from my cranium all the way down to my fingers and toes.  After a few days the fever and shocks subsided, but i got a terrible cough was weak.  I treated with OTC DayQuil for several days and finally on Oct 18 called my family Dr. near closing time. She told me I should go to Urgent care. I did so and saw a PA-C.  I told him I had not felt well since taking the covid booster and now had a painful cough.  They did a covid test which was negative and did an X-ray it was determined that I had bronchitis and was Rx'd augmentin and a strong cough medicine.  that helped the bronchitis, but I still suffer from weak spells and electrical shocks which leave me weak. It interferes with my ADL and I still don't feel normal.
Redness, swelling, severe joint pain of my left 1st metatarsophlangeal joint for four days. Fatigue  lasting four days.
Delayed reaction of severe left arm and neck pain beginning 3/30/21.  No fever, some tingling in left hand.  Severe pain lasted 6 days.  Still sore 2 months later.
A LITTLE SORENESS IN ARM; ABOUT 24 HOURS OF MALAISE; This spontaneous report received from a consumer via company representative via social media concerned a 79 year old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total administered, on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced a little soreness in arm, and about 24 hours of malaise (dose number in series 1) and it was reported as "I am 71 and wife is 79. We both were given J&J with only a little soreness in arm and about 24 hours of malaise. Second injection was without issue. Neither of us have had even a sniffle during the entire covid period. We have been taking an extensive targeted supplement regiment for over 20 years. We feel that had a great impact on the outcome." On an unspecified date patient received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total administered, on an unspecified date for covid-19 prophylaxis. The patient had no any adverse events with the following vaccination covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from about 24 hours of malaise, and the outcome of a little soreness in arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20220938857.
the vaccine may have been refrozen; No adverse event; 4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing) and PRODUCT STORAGE ERROR (the vaccine may have been refrozen).    No concomitant medication was reported.  The patient received expired original booster Moderna COVID-19 beyond 30 days after thawing and the vaccine may have been refrozen. Pharmacist stated that it was placed in the refrigerator and it was used about 1 week after arriving at the facility.  The vial was initially stored in the refrigerator on 29-Mar-2022, and the vial was administered to patients on 13-Apr-2022, 15-Apr-2022, 22-Apr-2022.  The vial did not undergo temperature excursion. Patient had no adverse events and was not pregnant at the time of vaccination.  No treatment information was provided.  This case contains information for the 2 of 4 adult patients described by the reporter.
After the vaccination I developed tremors in both my arms through my hands, it made me very sick. I have since recovered from them. I also started having migraines a lot frequently than before. I also have gotten skin rashes but I'm not sure if they are associated with that. I had to see a skin doctor for it.