chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cannot move legs; Fatigue; Stomach hurts; Vomited 6 times; Cramps in legs and couldn't move legs for 6 hours; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps in legs and couldn't move legs for 6 hours), VOMITING (Vomited 6 times), HYPOKINESIA (Cannot move legs), FATIGUE (Fatigue) and ABDOMINAL PAIN UPPER (Stomach hurts) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unavailable) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCLE SPASMS (Cramps in legs and couldn't move legs for 6 hours). On 27-May-2021, the patient experienced VOMITING (Vomited 6 times). On 28-May-2021, the patient experienced HYPOKINESIA (Cannot move legs), FATIGUE (Fatigue) and ABDOMINAL PAIN UPPER (Stomach hurts). At the time of the report, MUSCLE SPASMS (Cramps in legs and couldn't move legs for 6 hours), VOMITING (Vomited 6 times), HYPOKINESIA (Cannot move legs), FATIGUE (Fatigue) and ABDOMINAL PAIN UPPER (Stomach hurts) outcome was unknown.            No concomitant medication provided by the reporter no treatment information reported by the reporter   Reporter did not allow further contact
headache; chills; vomiting; diarrhea; I was light headed about 10 minutes; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient (no pregnant) received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 01Mar2021 07:00 (Lot Number: EN6200) at age of 69-years-old as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation  .  Medical history included hypothyroidism, allergies: sulfur. Concomitant medications included levothyroxine sodium (SYNTHROID); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); ergocalciferol (VIT D); calcium; fish oil.  The patient previously took amoxicillin and experienced allergies, clindamycin and experienced allergies.  The patient experienced headache, chills, vomiting, diarrhea on 04Mar2021 05:30 with outcome of recovered in Mar2021, light headed about 10 minutes on 04Mar2021 05:30 with outcome of recovered on 04Mar2021.  The patient took 1000 mg of Tylenol & sumatriptan. AE resulted in Doctor or other healthcare professional office/clinic visit.  No follow up attempts are possible. No further information is expected.
Employee reported that pt started having the symptoms the next day. Running nose, rash on the (L) thigh and bilateral shoulders, fever. Employee states pt was seen in the clinic and was diagnosed with measles.
No additional AEs or PQC reported; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 14-APR-2022, the patient received rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 milliliter, lot #1742464, expiration date: 20-SEP-2022, administered orally for prophylaxis. The vaccine was exposed to temperature of 47.8 Fahrenheit for 45 minutes. No previous temperature excursion was reported. No other information provided.  No additional AEs or PQC reported.
A 25-year-old male, 2 weeks status post anthrax administration the right deltoid, complains of firm painful nodule that he noticed one to 2 days ago. Exam demonstrates an approximately 3 cm superior to inferior firm, fixed, tender nodule/mass over the belly of the deltoid, moves slightly with deltoid activation.
24 hours following injection, experienced two welts- one at injection site, once below injection site. Described affected areas as red, swollen, warm to the touch and tight-feeling. Also described flu-like symptoms following injection: fatigue, cough, sneezing.
3/1/21 Client came to report her reaction she had 20 minutes after being vaccinated.  Her one finger tip is red and then other fingers and thumbs turned red on the tip.  She said she did not tell anyone and waited one hour in monitoring.  She then went home which is 15 minutes away from the clinic.  She said she almost could not walk up the 3 steps to the front door. She then had severe muscle weakness for a week. Saw her PCP who did Sars COV2 Total antibody and it was negative. He doesn't want her to receive a Pfizer because of her reaction and no Antibodies.  He wants her to receive a Johnson & Johnson vaccine instead.
Diarrhea, Fatigue, headache, injection site pain, injection site swelling, malaise, new or worsened join pain and new or worsened muscle pain.  more than 23 hours of severe all over pain, horrible pounding headache and nausea
This patient had a fever of 104 F with his first Prevnar. A temperature of 102 F with her second Prevnar (given separately from other vaccines) approximately 2 weeks later.
After my first shot my arm was sore but fine after a day. About a week later I noticed if I used the arm muscle it would burn at the injection site. Weeks later and I?m still feeling the burn.  Sometimes it burns in a larger area.  I chose my right arm for the second shot and it?s already less sore than my left.  The first shot was given like a punch in the arm. Quite painful. Maybe that?s what caused the reaction?
Information has been received from a physician via medical records concerning a 15 year old female. The patient's past drug therapy included the first and the second doses of ORIMUNE, on 18-JAN-1995 (lot # 314-436070014) and on 11-MAR-1995 (lot # 386-942-071473). On 15-NOV-1994 the patient was vaccinated with a first dose of RECOMBIVAX HB. On 18-JAN-1995 the patient was vaccinated with a second dose of RECOMBIVAX HB (lot # 611290/0048A) in her right leg and on 08-MAY-1995 the patient was vaccinated with a third dose of RECOMBIVAX HB (lot # 613667/1286A) in her right leg. Concomitant therapy given in 08-MAY-1995 included the third dose of DTAP and the third dose of DTAP + HIB (lot # 384-975), in her left leg. On 27-AUG-2010 the patient had a hepatitis B surface antibody test (<5 mIU/mL); it was reported that the patient did not developed immunity to hepatitis B virus after the initial hepatitis B vaccination. The patient also received the following vaccines: first dose of MMR II (lot # 615318/0470B, HSA), in her left arm on 16-NOV-1995; the fourth dose of HIBTITER (lot # m005LP) in her left arm on 15-FEB-1996; the third dose of ORIMUNE (lot # 430-18707342) on 02-MAY-1996; the first dose of VARIVAX (Merck) (lot # 620617/1105D) in her left arm on 18-NOV-1996; the fourth dose of ORIMUNE (lot # 457-8390795E) on 19-NOV-1998; the second dose of MMR II (lot # 626052/0230H, HSA), in her left arm on 19-NOV-1998; the first dose of BOOSTRIX (lot # AC5280246A) in her left arm on 02-SEP-2008; the first dose of MENACTRA (lot # U2422AA) in her left arm on 02-SEP-2008; the second dose of VARIVAX (Merck) (lot # 660560/0135X) in her left arm on 02-SEP-2008; and a first dose of TWINRIX (lot # AHAVB427BA) in her left arm on 04-JAN-2010. At the time of the report the patient's present status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Severe anaphylactic reaction; This is a spontaneous report from a contactable physician (patient's husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization; and influenza vaccine (INFLUENZA VACCINE, unknown manufacturer), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunisation. Medical history included ongoing allergy to iodine and penicillin. The patient's concomitant medications were not reported. Historical vaccine includes influenza vaccine for immunization where patient previously had a severe anaphylactic reaction. On an unknown date, the patient experienced a serious severe anaphylactic reaction. The event was considered as serious important medical event. It was further reported that patient experienced a serious severe anaphylactic reaction to the influenza vaccine (anaphylactic reaction) (unknown latency) following the administration of influenza vaccine and bnt162b2. It was unknown if the patient experienced any additional symptoms/event. It was unknown if there were lab data/ results available. The physician stated that he was an Infectious Disease physician and stated that his wife has an allergy to iodine and penicillin and has previously had a severe anaphylactic reaction to the influenza vaccine. He states that since she has had these allergies and reactions in the past he was looking into some research to see if he would recommend his wife to get the vaccine. He was asking for any information regarding the administration of the vaccine in 4 smaller doses rather than the current two dose series that was recommended. He reported that he understands the information may be limited and just wanted to check and see if there had been in studies done in this case. Advised that there was limited information on this topic but relayed that there are currently ongoing trials for pediatric patients that are being studies with a variety of different dosage amounts that may be helpful for him. It was not repotted if the patient received a corrective treatment for the event. At time of reporting, the outcome of event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of anaphylactic reaction due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided.
Injection site soreness (began ~1 hour after vaccine reception, minor, does not interfere with daily life esp. driving a car) Body ache (began at time specified in report, minor but noticeable, prompted me to lay down and attempt to take a nap)
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 1:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 1:15 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 75.73.  No concomitant medications were reported.  Batch number 014M20A administered on 28-Feb-2021 with temperature between 26-27 from 09:00 AM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Redness and itching around injection site. Started 2 days after receiving the immunization and has since improved some but still some redness and itching.
past medical historyof CHF, chronic kidney disease, coronary artery disease, presented to emergency room with short of breath, short of breath on exertion, edema, multiple admissions for the sameproblem.  The patient recently had a cardiac cath, but the patient needsanother cardiac catheterization. The patient also complains of cough.
INITAL PAIN FROM INJECTION TRANSFERRED TO SHOULDER PAIN AROUND THE INJECTION SITE FOR SEVERAL DAYS AFTER VACCINATION, THEN PROGRESSED TO SEVERE SHOULDER & NECK PAIN, AND HEADACHES VIRTUALLY EVERY DAY SINCE.  NOW AFTER 45 DAYS THE NECK AND SHOULDER PAIN ARE GETTING MORE SEVERE DAY BY DAY, AFFECTING EVERYDAY ACTIVITIES, SLEEP, AND MY ABILITY TO SIT IN FRONT OF A COMPUTER AND WORK A FULL DAY
Vaccines administered, pt. became pale, fainted, within 3 minutes of final immunization. Laid pt. down on exam table, applied cool compresses.
shingles; Information has been received from a lawyer concerning a case in litigation and refers to a male patient of an unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On or about 14-FEB-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, vaccination site, lot # and expiry date were not specified) as prescribed and/or administered by a healthcare provider at the physician's office for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The causality was related.
heavy bleeding- menstrual(7-11 days ////// more often migraines ( double the occurances//relpax//////////degenerated muscles on the left side of her spine - recently diagnosed by her chiropracter and claims her spine has shifted as result causing her to be 14cm unevenly carrying her weight requesting to see her mandatory for at least a year causing extereme back pain  - abnormal periods of which havent been able to steady without stopping them alltogether with birth controls //depo- & ortho
Patient was given the Pfizer shot for Covid about 2:45PM.  I ask patient to stick around for at least 15 minutes.  After about 10 to 15 minutes after the patient started to complain about some tightness in the chest, swelling in lips.   I took her blood pressure and it was elevated.  She started to get worst so I administered a EpiPen and call 911.  About 15 to 20 minutes later the EMT person showed up and took over.  They ask her if she wanted to go the hospital to be observed.  She agreed and they took her to the emergency room.
Within 24 hrs fever 101-102 degrees - then 3 days later had hives on arms torso and in mouth, went to her Dr given steroid shot and told to take BENADRYL. 10/30 - fever 99-100 and hives going away.
Patient presented to emergency department on 11/25/2021 with chest pain. Patient was found to be COVID-19 positive when screening for possible admission to hospital. Patient was asymptomatic. He was kept in observation and discharged home on 11/25/2021. He required no treatment for COVID-19 infection.
Immunization given on 2/27/02-Mom called 3/1/02 and states LT where immunizations given is warm to touch, swollen size of fifty cent piece and golf ball size. States area is soft, not hard, No fever, no difficulty moving legs, not sore to touch.
started coughing and coughing and coughing ever since.; This is a spontaneous report from a contactable consumer (Patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number:ER8737 and Expiry date was not reported), via an unspecified route of administration on 29Apr2021 at 13:00 (at the age of 39-years-old) in right arm as dose 2, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: ER2613 and Expiry date was not reported), via an unspecified route of administration on 08Apr2021 in right arm as dose 1, single for COVID-19 immunization. Time the Vaccination was given between 13:00-13:30 both the first and second dose. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations. Patient's Medical History including any illness at time of vaccination was none. No Family Medical History Relevant to AE(s). Relevant Tests was none. The patient had not received other products. Caller would like to know if a cough is a common side effect after receiving the second dose of the Pfizer COVID vaccine. Caller states she did an online report and regarding her side effect. Call then is taken over by the patient's mother. Consumer who states her daughter is coughing so bad she cannot talk to the Agent. The caller reports her daughter received the second dose Pfizer Covid Vaccine on 29Apr2021 and had no side effects until a couple days ago, on 01May2021, the patient started coughing and coughing and coughing ever since. Caller states she would be a health care provider since she's a mom. Caller clarified she is a consumer and not an HCP. Caller states her daughter does not have a primary care physician. Caller states her daughter is concerned about the coughing, wants to make sure her daughter is not dying or anything right now. The patient was not visited to emergency room and physician office. The outcome for the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Small patches of breakthrough (pso) spots; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced small patches of breakthrough (pso) spots, coincidently about the time she had got her COVID-19 vaccine. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected. Batch/lot number not obtained.
sever head ach,  stiff neck, freezing chills to sweating,aching all over  not feeling good
Patient was noted to be sitting in chair doing fine then made gurgling noise. She was posturing with clinched jaw and tonic muscles. She was moved to the floor feet up. Airway was managed. She lost control of her bladder. The episode lasted approximately 30 sec. She came around & started crying. She was diaphoretic but no nausea.
05/01/23 - Vaccine doses given as above. 05/04/23 - Seen in UC for left thigh - possible injection site inf. Cephalexin monohydrate prescribed. (I noted appt on 5/23/23)05/08/2023 - F/U call not answered - 0 return call. 05/22/2023 - While preparing to complete inventory, I noted a discrepancy - I contacted nurse to verify doses given/incorrect documentation - She confirmed given as documented.  Parents notified.
AROUND 10PM THE DAY OF VACCINATION DEVELOPED HEADACHE, LOW GRADE FEVER, CHILLS, FATIGUE, MUSCLE ACHES AND JOINT PAIN.  SHE MISSED WORK THE NEXT DAY, DID NOT SEE PHYSICIAN, DID NOT TAKE ANY MEDICATION. SYMPTOMS LASTED 18 HOURS, AND SHE WAS COMPLETELY BETTER WITHIN 48 HOURS
Confusion between vaccinations (H-BIG and Baby-BIG), similar names causing confusion.
Engerix B peds dose was given to an adult patient; Engerix B peds dose was given to an adult patient; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 51-year-old male patient who received HBV (Engerix B pediatric) (batch number 722KC, expiry date unknown) for prophylaxis.   Previously administered products included Engerix B (1st dose received on unknown date).   On 30th March 2021, the patient received the 2nd dose of Engerix B pediatric. On 30th March 2021, unknown after receiving Engerix B pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the pediatric dose instead of adult which led accidental underdose and adult use of a child product. The reporter inquired that could the 3rd adult dose would be given and when. The reporter consented to follow up.
Went for a light run about 3 hours after the vaccine. Had heart palpitations while running. Upon walking the rest of the way home, sat down and had a bout of SVT where heart rate went to 210 for about a minute.