chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe rash over my entire body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (severe rash over my entire body) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced RASH (severe rash over my entire body). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) ongoing since an unknown date for Rash all over, at a dose of about a week. At the time of the report, RASH (severe rash over my entire body) outcome was unknown. Not Provided          Concomitant medications were not provided.   Patient was prescribed Prednisone & Benadryl. She admits having only taken the Benadryl for about a week.   Patient got second shot of moderna vaccine after that and had no problems at all.
onset of abdominal cramps, severe h/a, extreme weakness, fever x 48 hrs, malaise, diarrhea, & vomiting for 3-4 days post vax; t101;
On 12/9/05 child started getting a runny nose and congestion.  Not eating well, fussy, and irritable.  This continued through 12/12/05.  On the morning of 12/13/05 woke up with severe rash all over body from scalp to feet.  Bright red pinpoint dots all over body, blotchy looking on back, buttocks, and backs of knees.  Went to Pediatrician that morning.  Child has ear infection, respiratory infection, and eye infection in addition to the rash.  Still not eating and irritable.
determined to be immunocompromised after half dose booster; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNODEFICIENCY (determined to be immunocompromised after half dose booster) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (determined to be immunocompromised after half dose booster) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (determined to be immunocompromised after half dose booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product was provided by the reporter. No treatment medication was provided.  Company comment: This is a spontaneous case concerning a male patient of unknown age with no medical history reported who experienced the unexpected and serious (medically significant) event of immunodeficiency after a booster dose of mRNA-1273 vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. Reported stated that the patient was determined to be immunocompromised after receiving half dose of booster. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no medical history reported who experienced the unexpected and serious (medically significant) event of immunodeficiency after a booster dose of mRNA-1273 vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. Reported stated that the patient was determined to be immunocompromised after receiving half dose of booster. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
pt recv vax in 1981 & lab eval on 31AUG94 revealed anti-HBc pos, anti-HCV negative, HBsAg neg & serum cholesterol 227; lab eval on 12OCT94 revealed anti-HBS & anti-HBc pos; No further info was provided;
Patient stated to this nurse @ 1100.  Stated she had pain @ injection site to L arm.  States that, "the needle went in to deep and touched her bone".
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 (Lot number: FK5127) at the age of 5 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Pyloric stenosis", start date: 2016, stop date: 2016, notes: Pyloric stenosis repaired 2016. Concomitant medication(s) included: FLU VACCINE VII, administration date 23Oct2021. The following information was reported: LETHARGY (non-serious) with onset 13Nov2021 10:00, outcome "recovered" (2021), described as "Lethargy"; MALAISE (non-serious) with onset 13Nov2021 10:00, outcome "recovered" (2021), described as "Malaise". Therapeutic measures were not taken as a result of lethargy, malaise. Additional Information: The patient had no other vaccine in two weeks. The patient had no Covid prior vaccination. The patient not tested Covid post vaccination. No follow-up attempts are possible. No further information is expected.
pt recvd 3 doses of Engerix-B & noticed hair/loss/breakage since JAN944;
Immunocompromised; This is a spontaneous report from a Pfizer-sponsored program, received via a contactable consumer. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13,Solution for injection in pre-filled syringe, lot number/expiration date unknown) via an unspecified route of administration on 08Nov2020 at a single dose for immunization. Medical history included Crohn's. Concomitant medications included infliximab (INFLECTRA) for Crohn's. The patient was told by her doctor she should get a dose of Pneumovax 23 vaccine in 8 weeks due to her being immunocompromised. However, the pharmacist told her that she should wait for one year. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Swelling at injection site; Fever of 104--alternating ibuprofen and acetaminophen with no decrease in temp or pain; Headache; Body aches; Chills; Fatigue
Initial information received on 11/10/2006 from a health care professional. A female pt (age and date of birth not reported) received an injection of Menactra, lot number U1948AA, on 11/1/06. The route and site of administration were not reported. Within 24 to 36 hours post administration, the pt developed pneumonia and was hospitalized for one week. The pt was treated with Rocephin and Levaquin. She had a negative culture. The reporter stated that the pt had no signs or symptoms of meningitis and has recovered from the event of pneumonia. The reporter of this case is the same as for case 2006-03060, which also involves pneumonia following Menactra vaccination.
Tdap vaccine given at this visit. Tdap vaccine also previously placed at another facility on 09/25/2020.
c/o numbness and pain in left arm at the site of the flu vaccine immediately after administration.  For the next two days after the vaccine, she felt tired and slept.  The third day after the vaccine (11/5) the patient had a rash and itching on her left arm and felt ill.
On Sunday, january 31, 2021 I feel itching where the vaccine was applied and I checked in there it was very red, The redness is been increasing in size and getting better about the itching. Today I have a black/brownish  spot in there.
This non-serious spontaneous case, initially received from other health professional (nurse) on 15-Mar-2018, concerning a 35-year-old, adult, male patient. On an unspecified date first temperature excursion of the vaccine occurred. On 29-Jan-2018, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XT59906, expiry date: 06-Jun-2018) after first temperature excursion. On an unspecified the vaccine was stored out of range for 65 hours and 35 minutes, reaching a highest temperature of 60 F which was the fifth (5th) excursion with those vaccines. It was reported that, the patient did not experience any adverse event after vaccination. Follow up report received from other health professional (nurse) on 16-Apr-2018: The route of administration (intramuscular) of the suspect vaccine was added. It was reported that, the patient did not experience any adverse event after vaccination. The narrative was amended accordingly.
Pt not in acute distress and not toxic-appearing. Mild erthema at L deltoid injection site. Firm mass of approximately 1 cm diameter present. No drainage. Low suspicion for cellulitis at injection site. Full strength in LUE on exam. Decreased flexion of L shoulder on exam s/t pain. Prednisone now ordered for vaccine injection site reaction. Advised pt to use APAP for pain. Instructed pt not to use ibuprofen while taking prednisone since concurrent use of these two meds can increase risk for GI bleeding. Advised pt to interchange use of hot and cold compresses for 20 minutes at a time. Advised pt to go to the ED if experiencing severe pain or numbness in affected extremity. Pt agreeable to this plan. Provided pt with educational material regarding prednisone and the tdap vaccine.  Pain of left upper extremity -     predniSONE 20 MG tablet; Take 2 tablets daily for 2 days, then 1 tablets daily for 2 days, then 1/2 tablet daily for 2 days, take with food or milk   Erythema at injection site -     predniSONE 20 MG tablet; Take 2 tablets daily for 2 days, then 1 tablets daily for 2 days, then 1/2 tablet daily for 2 days, take with food or milk
Information has been received from a healthcare worker reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions/allergies, pertinent medical history or concomitant medication. On 02-NOV-2017, the patient received an improperly stored dose of LIQUID PEDVAXHIB lot # N012120, expiration date 30-JAN-2020 or lot # N000235, expiration date 26-OCT-2019 or lot # N007749, expiration date 29-NOV-2019 for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that on an unspecified date, the vaccine was exposed to a temperature between 9 Celsius degrees and 25 Celsius degrees for 47 hours and 39 minutes. The vaccine did not undergo a previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects were reported. This report is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1711USA006083: US-009507513-1711USA013916: US-009507513-1711USA013917: US-009507513-1711USA013919: US-009507513-1711USA013920: US-009507513-1711USA013921: US-009507513-1711USA013913: US-009507513-1711USA013914: US-009507513-1711USA013915.
PATIENT TOLD ME HAVE THE AREA RED, SWELLING, VERY PAINFUL, ITCHY AND TINGLING.
Patient had a tonic clonic seizure lasting 20-30 seconds just after receiving immunizations. Postictal was alert and oriented. Denies any hx of seizures or any previous reaction to any immunizations. Sent to ER. MENACTRA and IPV taken from VFC instead of private.
Patient received PNEUMOVAX on 10-14-13 and called us on 10-15-13 stating arm is red from elbow to shoulder and hot to touch. Patient was to use cool compresses and ibuprofen 200 mg 1 or 2 every 8 hours.
While waiting my 15 min after vaccination at our pharmacy, I began to feel nauseous. I developed a accelerated heart beat wich went back down after a couple of minutes. After my 15 min wait period, I left to return to work (store) but felt pain in my left leg and left hand then numbness in my left leg. I texted my manager and was instructed to leave early. On my drive home, within another 10-15 min I started developing a headache. I ended up having a headache and COVID like symptoms for almost 3 days. These symptoms were worse than what I experienced after my first vaccine dose on 10/05/2021 and occurred much faster.  During my first dose I felt fine to return to work. The next day I wasn't feeling well and that lasted 2-3 days but was less severe.
About 27 hours after the injection, and after I was mostly thru strong muscle and joint pain, I had severe pain in the tooth that will need another crown; it was an 8:10.  It lasted about 5-10 hours (not sure as I did fall asleep and when I woke up it was largely gone). I had taken a Tylenol which helped for a while; the severe pain returned; I then took another Tylenol which didn't help; I took an ibuprofen and chewed on some cloves and that helped.
Information has been received from a physician concerning a 6 month old female who on 31-MAY-2007 was vaccinated with a third dose of Rotateq. On 31-MAY-2007 the patient experienced vomiting. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
pt recvd vax 15DEC94 & felt warm-mom gave APAP; 16DEC94 AM woke up 930 & had welts; no fever; mom called MD who advised given DPH;
Patient was sitting in chair after vaccine waiting the required 15 minutes. He states he was staring sown watching his phone and he felt hot and then woke up on the floor with people around him. He fainted. He felt hot and sweaty afterward. Episode seemed to pass within about 10 minutes all together. Paramedics came and checked him out since he hit his head when he fell. Patient didn't want to go to hospital and was picked up from the store by family member.
0.25ml influenza vaccine was administered as the first vaccine for the 2017-2018 flu season. 0.5ml is the recommended dose for this vaccine. No adverse reaction was observed or reported. Parents have been contacted to bring child to clinic for revaccination at no cost.
Pt received bivalent booster instead of pfizer monovalent dose 1. The bivalent booster was expired by 12 hours. Pt reported no known side effects.
Patch of red the size of a silver dollar on the left arm next to the injection site, which lasted 3 days and then went away. The rash returned about 4 days later, it was large (about 3 inches wide, 4 inches tall). The rash was very red and very very itchy. Treated with hydrocortisone cream, which calmed it down after about 4 or 5 days. The red mark is still there and itches slightly, but not severely any longer.
Pt recvd Heptavax series in 1984, Recombivax series in 1987 & 1 dose of Engerix-B  in 1988; booster dose of Hep B vax in NOV90 pt had short duration of protective titer levels; no other info is available @ this time;
He has a knot under vaccine site and it has a rash around it. I gave him a warm compress, tylenol and benadryl.
Heavy spotting the day after vaccination, 14 days into cycle.; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 20Dec2021 (Lot number: FE3590) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EW0169), administration date: 27Apr2021, when the patient was 29 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EW0150), administration date: 06Apr2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021, outcome "unknown", described as "Booster"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 21Dec2021, outcome "recovered", described as "Heavy spotting the day after vaccination, 14 days into cycle.". Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional information: Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The past drug event was none. The facility type vaccine was Other. The patient experienced heavy spotting the day after vaccination, 14 days into cycle. Spotting was not a normal occurrence. The patient had not been sexually active for almost 2 years.  No follow-up attempts are possible. No further information is expected.
Headaches; Legs going numb; Nausea; Chest pains-right side; Joint pains; Lower right abdominal pains; Chronic fatigue; Mood changes-light Hair loss-noticed in shower; Back pain. Now the left side of abdomen hurts-more than Right.
pain in arm but nothing else; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in arm but nothing else) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included AMOXICILLIN for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in arm but nothing else). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in arm but nothing else) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 34-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FLUOXETINE from 15-Dec-2020 to an unknown date for Anxiety.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 23-May-2021. On 27-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  The patient was treated with MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, at a dose of UNK, qd. On 27-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Blood test: normal normal. In December 2020, Ultrasound foetal: normal (normal) normal. On an unknown date, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient previously had live, full term birth on 02-MAY-2006, 31-MAY-2007 and 17-JAN-2019 and there were no complications in mother or the infant.    The patient did not have any complications or acute illnesses during this pregnancy till date.   This case was linked to US-MODERNATX, INC.-MOD-2021-060459 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060459:Cross Linked case
Pain in my left Arm that is limiting my capacity to use my left arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient.   A 40 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 14:45 (Lot number: FH8030) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Type II diabetes" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; SIMVASTATIN. Vaccination history included: Bnt162b2 (Dose Number: 2, single, Batch/Lot No: EL9269, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 05Feb2021, when the patient was 40 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, single, Batch/Lot No: EL3249, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 15Jan2021, when the patient was 39 years old, for COVID-19 Immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 12Dec2021 14:45, outcome "not recovered", described as "Pain in my left Arm that is limiting my capacity to use my left arm.". Therapeutic measures were not taken as a result of pain in extremity.   Additional information: Facility where the most recent COVID-19 vaccine was administered included Public Health Clinic/Veterans Administration facility. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was Unknown. The patient received medications within 2 weeks of vaccination included Metformin 500 mg and simvastatin20 mg. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
pt recv vax & exp exacerbation of carpal tunnel synd (CTS);reportedly this might have happened p/1st dose of post exposure treatment series;pt reportedly had a past medical history of CTS & has been treated successfully;
Developed a bump on her right arm where she had the shot/she got her 2nd dose of the Pfizer COVID 19 vaccine on her left arm and had another bump; This is a spontaneous report from a contactable consumer (patient). A 18-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: Not reported, Expiry Date: Not Reported), via an unspecified route of administration, administered in Right Arm on 13Aug2021 as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: Not reported, Expiry Date: Not Reported), via an unspecified route of administration, administered in Left Arm on 03Sep2021 as dose 2, single for covid-19 immunization. The patient received hpv vaccine (HPV VACCINE), via an unspecified route of administration on 18Aug2021 (Batch/Lot number was not reported) to 18Aug2021, as dose number unknown, single for immunization. The patient medical history and concomitant medications were not reported. Patient called to report side effect of the Pfizer COVID 19 vaccine - She received the 1st dose of the vaccine on 13Aug2021 and 2 weeks after she developed a bump on her right arm where she had the shot - On 18Aug2021 she received a HPV vaccine - 03Sep2021 she got her 2nd dose of the Pfizer COVID 19 vaccine on her left arm and had another bump - She was advised to call her provider if she will develop another bump - When she tried to call her provider, she was referred to us - Asking on what to do. The reporter assessed the seriousness of the case as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a other health professional refers to a patient of unknown age who on 05-MAR-2014, was vaccinated subcutaneously with a 0.5 ml dose of PNEUMOVAX 23 (lot number 0653AE) that was expired. The vaccine expired on 10-FEB-2014. No adverse effects were reported. Additional information has been requested.