chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe abdominal pain; Vomited; I felt kind of yucky; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 at 11:30 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic pancreatitis hypoglycemia due to type 1 diabetes mellitus. Concomitant medications included insulin (MANUFACTURER UNKNOWN), pancreatin (CREON), pantoprazole sodium sesquihydrate (PROTONIX) and vitamin d nos (VITAMIN D) all taken on unknown date, for unknown indication. The patient previously took boric acid (MANUFACTURER UNKNOWN), ibandronate sodium (BONIVA), fluconazole (DIFLUCAN) all for unknown indication, from an unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on 05Mar2021 at 11:00 (at the age of 66-year-old) as a single dose for COVID-19 immunisation. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 Saturday, one day after the vaccination, the patient felt kind of yucky, but ate small meals. On Saturday night at 1900 the  patient started feeling severe abdominal pain and double over. The patient sat down with feet up hoping it would subside but it didn't, it got worsened. On 22:20, the patient was in the bathroom hoping to go but not much would come out, patient did throw up. Since in 19 years, first time the patient brought up mostly flem and specs of food. After that, patient reported that some of the pain went away but it continued on Sunday 28Mar2021, but the patient did not have any vomiting. The clinical outcome of the events felt yucky (nausea) was unknown and severe abdominal pain was recovering at the time of this report. The clinical outcome of the event vomiting was recovered on 28Mar2021.   No follow-up attempts are needed. No further information is expected.
a little sick; Didn't want to do anything; Tired; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (a little sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Didn't want to do anything), FATIGUE (Tired) and MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced ILLNESS (a little sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Didn't want to do anything), FATIGUE (Tired) and MYALGIA (Body aches). At the time of the report, ILLNESS (a little sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Didn't want to do anything), FATIGUE (Tired) and MYALGIA (Body aches) outcome was unknown.            No concomitant medication were given. The patient received the 2nd booster. No treatment information were given.   Reporter did not allow further contact
red under where it was injected; felt warm; elbow pain; hurt down to my elbow; Still hurts to left my arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  In August 2021, the patient received the 1st dose of Shingles vaccine. In August 2021, several hours after receiving Shingles vaccine, the patient experienced pain in arm, injected limb mobility decreased and pain in elbow. On 20th August 2021, the patient experienced erythema of extremities and feeling of warmth. On an unknown date, the outcome of the pain in arm, injected limb mobility decreased and pain in elbow were not recovered/not resolved and the outcome of the erythema of extremities and feeling of warmth were recovering/resolving.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, erythema of extremities, feeling of warmth and pain in elbow to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine and hurt bad down elbow a few hours later, and still hurts to lift patient arm. it's red under where it was injected felt warm last night less today. The patient stated that he/she didn't expect that. The follow up would not be possible as no contact details were available.
Patient was administered with both vaccines that were at 35.2F for 1:05 duration time.
Pt recvd 2 doses of Heptavax 10JAN91, 19FEB91 & 1 dose of Engerix-B 23JUL91; pts blood is drawn monthly; As of 10OCT91 blood tested neg;
Initial tingling and burning of low back to leg then rash with blisters on a red base from about L4 to the anterior thigh.
Event occurred after 2nd dose. Patient was diagnosed of COVID 19 Remdesivir In-patient
Heart racing 80 bpm resting cold sweats nervousness light headed and dizzy constant heart flutter !!! all the time  shaky hands  hot flashes
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. Information regarding the patient's past medical history, concurrent conditions, or concomitant medication was not provided. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 30-MAY-2012, as recommended for routine adult health maintenance for the prevention of shingles. It was reported that the ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-DEC-2013, the patient was treated for a painful rash that was diagnosed as shingles. On or about 24-APR-2015, the patient was treated again for ongoing and worsening symptoms of a shingles outbreak. While shingles is an incurable viral condition, she was prescribed acyclovir to manage her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
pt recv vax 21AUG97 & in SEP97 pt exp upper resp sx & was tx w/Amoxil;6SEP97 pt exp varicella-like rash;the reporter stated that the rash appeared p/pt was given amoxil but rash is not like an ATB rash;
Tinnitus, Dizziness, Weakness, Fever, Body Aches - All adverse events lasted for a week, with the exception of the dizziness and tinnitus, which is persistent. On Feb. 25th I got extremely dizzy and had a syncopal episode, injuring my abdomen, which required a call to paramedics and the transfer to a trauma hospital for treatment of large abdominal wound. Long term wound care was required, and ended on April 16th, 2021.
tested positive for Covid-19; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for Covid-19) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) 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.   No concomitant medications were provided. No treatment information provided.
Upon review of vaccine reports, noticed patient received a bivalent dose of pfizer vaccine without having completed the primary series.  No adverse reactions noted from visit.
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that make sure you would get full treatment of two shots of shingles vaccine. The patient got one shingles shot and still got shingles. The patient was knowing he/she was supposed to take 2 shots of the shingles vaccine. The follow up would not possible as no contact details were available.
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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2021 as dose number unknown, single (Lot number: FR8734), in left arm, on 24Apr2021 as dose number unknown, single (Lot number: EW0170), in left arm and on 17Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Sulfur, reaction(s): "Allergies: Sulfur". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient had COVID-19 with Paxlovid, Treatment start date: 01Aug2022. Patient had no other medication in 2weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax; devel fever to 103, a morbilliform rash, diffuse lymphadenopathy & swollen lymph nodes in the groin & rt salivary gland;to MD;rash & fever resolved p/ 2 days; recovered fr lymphadenopathy
Test positive for Covid; Test positive for Covid; 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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 1, single (Lot number: EW0153), in left arm, on 03May2021 as dose 2, single (Lot number: EW0167), in left arm, on 21Aug2021 as dose 3 (booster), single (Lot number: FC3180), in left arm and on 12Feb2022 as dose 4 (booster), single (Lot number: FJ6369) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MS -taking ocervus immunosuppressant to manage" (unspecified if ongoing); "known allergies: peanuts" (unspecified if ongoing); "known allergies: gluten (celiac)" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Flu vaccine, for immunization, reaction(s): "allergic to flu vaccine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Apr2022, outcome "unknown" and all described as "Test positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Positive; (03May2022) Negative; (06May2022) Postive, notes: Test positive for Covid again,Symptoms continue and are getting worse, not better. Therapeutic measures were taken as a result of covid-19.
This spontaneous report as received from a registered nurse refers to a 5 year old male patient. Patient had no pertinent medical history. Patient received separate doses of M-M-R and VARIVAX previously in January 2009 without difficulty. Patient has allergy to red dye. The patient was vaccinated with dose 1 PROQUAD (merck), subcutaneously, on 03-JAN-2013. Dosing information was not provided. Two lot number were provided: H019918 and H01577 (1 lot number for PROQUAD and lot number for the sterile diluent for PROQUAD); expiry date: February 2014. No other co-suspects were reported. No concomitant medications were reported. Immediately after first dose the patient experienced tight, wheezing cough, lethargy, low oxygen saturation, poor perfusion and dusky color in his fingers and toes, paleness in his face and swelling of lips and face. The events were assessed to be lifethreatening and disabling. Patient was treated with 2 nebulizer treatments, oral BENADRYL (manufacturer unknown), which the patient coughed up, followed by an intramuscular administration of BENADRYL and an EPIPEN JUNIOR (manufacturer unknown). Patient was transported from the office to the hospital where he was admitted. The nurse mentioned that the twin brother of the patient received a dose of PROQUAD (merck) from the same lot number/expiration date and no adverse symptoms were reported. The outcome of the events was reported as recovering/resolving. The relatedness for the events for PROQUAD (Merck) was not provided. Merck considered the events to be medically significant, as these are hypersensitivity symptoms treated with epinephrine. Additional information has been requested.
Information has been received from a registered nurse concerning a 9 month old male patient with no pertinent medical history or allergies who on 22-MAY-2009 was vaccinated intramuscularly with a 0.5 ml dose of RECOMBIVAX HB (663314/0089Y) (thimerosal free)). Concomitant therapy included hepatitis B immune globulin. It was reported that the patient also received two doses of ENGERIX B followed by RECOMBIVAX HB. On 01-MAR-2010 the patient was diagnosed with hepatitis B. On 01-MAR-2010, hepatitis B antibody testing was negative; hepatitis B surface antigen and hepatitis B core IgM testing were positive. Unspecified medical attention was sought. The patient had been referred for evaluation. At the time of this report, the patient had not recovered. Additional information has been requested.
Patient was sitting in the chair and then fell onto the floor head first causing him to bump his head and also hit his nose. He appeared to have a bump on his forehead and his was bleeding.
During our count of vaccines after clinic it was noted that the patient received both a vaxelis and polio vaccination. A call was placed to the parents to notify of the inadverent error of giving vaxelis and polio at the same time. The patient has not had any adverse reactions due to this event.
This case was reported by a consumer and described the occurrence of shooting pains in a 50-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included fractured neck which resulted in paralysis of one lung. Concurrent medical conditions included exercise induced asthma, high blood pressure and muscle spasm. Concurrent medications included PROZAC, anti-viral medication, clonidine, ibuprofen, FENTANYL and tizanidine. In October 2011 the subject received a dose of FLULAVAL in the right arm (2 inches above his elbow in the side of his right arm). Within 24 hours of vaccination with FLULAVAL, the subject experienced shooting pains, fever (in his arm) and red skin. He described the pain as severe pain that felt like electrical shocks (electric shock sensation in arm). These events were described as worse at the time of reporting.  The subject also reported that he developed systemic problems such as intermittent blindness, prostate problem, migraines, worsened breathing and swallowing difficulty. The subject stated that every day he "feels like he is dying" and it was getting worse. The subject was very anxious over his symptoms and was not sure if FLULAVAL was the cause of his worsening condition. It was reported that an MRI and EKG performed on unspecified dates revealed normal results. The subject additionally reported that following previous flu shots, he developed pain after the injections. No further details were provided.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.  On 03-Apr-2021 at 2:54 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 51.67  Concomitant products were not provided.  On 11-Jan-2021, Excursion time was 9 AM temperature was 34 total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, 3 vial was moved to clinic on 3-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
redness and itching noted to left arm injection site as of 1/30/21. Improvement noted by 2/1/21
Feel sick; This case was reported by a other health professional via Shingrix interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient felt sick after receiving Shingrix.
Information has been received from a licensed practical nurse concerning a 14 year old female with no pertinent medical history or drug reactions/allergies on 27-FEB-2007 was vaccinated with a first dose of GARDASIL (lot# 654335/0960F) 0.5mL. The date of the last menstrual period was 03-JUN-2007. On 26-JUN-2007 the patient was vaccinated with a second dose of GARDASIL (lot# 658094/0524U). On the same day a urine pregnancy test was performed prior to vaccination and the results was negative for pregnancy. On 12-JUL-2007 a urine test was performed and the results was positive for pregnancy. Medical attention was sought. The estimated date of delivery is 09-MAR-2008. No symptoms have been reported. Follow-up information was received from a health care professional. The HCP indicated that the patient either had a miscarriage or an elective abortion on 02-AUG-2007. No additional information was available. Upon internal review unspecified abortion is considered to be an other medical event. Additional information is not expected.
04/23/04 AM Client has "Small, red bumps on inner thigh and under arm. Not purulent as of AM.  Client feels "warm" (temp not taken) and is "Cranky" (Reported by parent).
Pediatric Covid vaccine was given to a 14 year old female. PCP notified.
did not get my second dose (COVID)); firmness at the site; Pain at the site; Headache; Myalgia; This case was reported by a consumer via interactive digital media and described the occurrence of injection site induration in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   On 23rd March 2021, the patient received the 2nd dose of Shingrix. In March 2021, less than a week after receiving Shingrix, the patient experienced injection site induration, injection site pain, headache and myalgia. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the injection site induration, injection site pain, headache, myalgia and social problem were unknown.   It was unknown if the reporter considered the injection site induration, injection site pain, headache and myalgia to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. A day before reporting, the patient received the 2nd dose of Shingrix and had the funky symptoms in a bad way which was myalgia, headache, pain and firmness at the site. The patient received 2nd dose of Shingrix later than the recommended schedule because of COVID. Note: As the patient already received 1st dose in November 2019, thus the dose received on 23rd March 2021 was considered as 2nd dose although it was reported as a 1st dose. Thus, case was considered for the 2nd dose considering that it was a typo error.