chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of throbbing pain in a male patient who received Influenza vaccine. On 23rd October 2014, the patient received Influenza vaccine. On 23rd October 2014, 10 min after receiving Influenza vaccine, the patient experienced throbbing pain. On an unknown date, the outcome of the throbbing pain was unknown. It was unknown if the reporter considered the throbbing pain to be related to Influenza vaccine. Additional information received: A patient reported getting a flu shot this morning at about 9 am. About 10-15 min afterwards the patient experienced aching, throbbing pain in his left arm that runs all the way down past his elbow. The patient said this comes and goes and seems to hurt most if he is walking or moving. No other details were provided.
This case was reported by a physician (also the subject) and described the occurrence of pain in subject of unspecified age and gender who was vaccinated with TWINRIX for prophylaxis. On an unspecified date the subject received unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced a little pain. At the time of reporting the outcome of the event was unspecified. These events occurred in a number of different subjects from the same source, but with difference contacts. Linked case included A0732483A, A0732491A, A0732492A, A0732500A, A0732591A, A0732515A, A0732528A, A0732533A, A0732539A, A0732540A and A0732936A.
pt recvd vax; tenderness at inject site for over a week, then mult blotchy puritic areas on arm but not directly at site;
Chills; Mild Fever; Sore all over; Sick; like she had the flu; Arm Hurts; Dizzy; This is a spontaneous report from a contactable consumer. A 44-year-old female consumer (Patient) reported for that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8731, Expiry Date: not reported), via an unspecified route of administration, administered in left arm on 17Apr2021 at 17:21 (at the age of 44 years) as dose 2, single for covid-19 immunisation. Patient had no medical history. Family medical history relevant to AE(s) was none. Denied any medications, medical conditions, labs, testing, or treatments relevant to the report. Caller mentioned that her 83 year old mother had the vaccine with no effects. No further information provided by caller. The patient's concomitant medications were not reported. Past drug included flu vaccine (No NDC, Lot Number, or Expiration date known) on an unspecified date and experienced sore arm on unspecified date. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8730, Expiry Date, NDC number: not reported), via an unspecified route of administration, administered in left arm on 27Mar2021 as dose 1, single for covid-19 immunisation. The patient took Covid vaccine as she did not want to be really sick and wanted to get on with life. Vaccine was not administered at military facility. No investigation assessment done. Prior Vaccinations (within 4 weeks) was none. Additional vaccines administered on same date of the Pfizer suspect was none. Caller stated that she had the vaccine on 17Apr2021 and her symptoms began the next day on 18Apr2021. The patient experienced chills, mild fever, sore all over, sick like she had the flu, arm hurts and dizzy on 18Apr2021. Caller stated that she wanted to ensure she was not contacted any further about the report. Stated that she felt her reaction was standard. Patient did not visited emergency room or physician office. Stated that she took Tylenol three times a day to help with her symptoms; had not taken any yet till the time of report. The outcome of events chills and mild fever was recovered on 19Apr2021 while the outcome of other events was recovering.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021459170 same reporter/vaccine different patient/event
vomiting, diarrhea, & eyes burning & red; was 1st flu shot; hard time breathing p/630PM; did not go to MD; taking APAP & resting;
Fever > 101-102. Chills > 8 hours. Took ibuprofen, fluids and aspirin all night.
Severe headache, dizziness, mild nausea, chills that lasted 5 hours, with milder headache and fatigue for another day
Client reports onset of soreness by noon on day of vaccination in arm where PPV was administered.  Arm became red, swollen, painful and "hard" from 2" below injection site to just above the elbow.  Iced and was prescribed prednisone by MD. Resolved; no follow up needed; advised to avoid further PPV revaccination.
Pt was seated in chair and directly after the immunization IM left deltoid pt became rigid and had episode of syncope, slumping in the chair and his mothers arms, lasting approximately 10 seconds.  Dr did assess pt was observed for about 45 min. laying down and transitioning as tolerated to standing position.
No Adverse event; patients received doses from affected vials by a temperature excursion; doses administered from vials that underwent a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered from vials that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (patients received doses from affected vials by a temperature excursion) and NO ADVERSE EVENT (No Adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients received doses from affected vials by a temperature excursion). In September 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered from vials that underwent a temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered from vials that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (patients received doses from affected vials by a temperature excursion) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered from vials that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients received doses from affected vials by a temperature excursion).    No concomitant medication were reported.  The duration of the excursion was 1 hour on 02-SEP-2022. The vials were under frozen condition at the time of the excursion and individual vials were in the box of vial size 2.5ml. The maximum temperatures reached was -12.5°C, the vials had not moved from freezer to refrigerator and there was no any vaccine state change found by visual inspection.  No treatment information was provided by the reporter.
3/29/2021 - Present: Extreme vertigo, lightheadedness, weakness, chest pain, increased migraines, fatigue, night sweats and numbness in extremities. Other sporadic symptoms: Heart palpitations and brain "zaps." I now require use of a walker on most days and cannot stand for more than a few minutes without getting dizzy or feeling as if I will pass-out. I have to attend physical therapy weekly.
left hand numbness, then progressed to tenderness under left arm, around deltoid, radiates to back, swelling. Went to Urgent Care. RX Tylenol, cold/hot presses
Patient was 6wks pregnant when she received the vaccine at a public vaccine clinic on Oct. 30th. Her expected date of delivery was 7th April 2010. She suffered miscarriage on Nov. 13th, 2 weeks later. She had a history of blood clots. This was her first pregnancy, and she didn't have any complication related to her pregnancy. She did not have any other vaccines during the pregnancy. Her doctor told her that he didn't find any reason to believe that the miscarriage was due to anything other than natural causes.
24 hrs after receiving rabies vaccine on 3/5/06 developed generalized muscle aching. Denies any associated fever, shortness of breath, chest pain, angio edema, urticaria or localized erythema, induration or tenderness. Donor drank extra Gatorade within complete resolution of symptoms within 1 hour.
Patient received the updated Pfizer Bivalent COVID vaccine on 9/20/22 at local pharmacy in the left arm. She reports that she has had pain in her left arm since the vaccine was administered though it is slowly getting better. She does report 2 autoimmune conditions but did not report the exact nature of those conditions.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 33rd of 43 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689222:master case
I had a sore arm at injection site that lasted for a day. I started not feeling well on 09/19/2022 with a severe sore throat, lost my voice, achy all over, congestion, coughing and my tongue was white. I tested positive for COVID-19 on 09/20/2022 via a home test. I contacted my doctor and was prescribed PAXLOVID. Today, I have a little cough that is lingering and dry mouth.
Patient developed large lump around injection site that was hard, painful, and warm to the touch. Lump continued to get larger over days after vaccination. Diagnosed by patient's doctor as cellulitis.
Pt states he still has arm pain and pain with lifting arm 3.5 weeks after receiving vaccination. Pt following up with MD.
Headache; Feeling like have a cold; feeling sick; This is a spontaneous report from a contactable consumer (patient).   A 47-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Batch/lot # EL3249) at single dose at left shoulder on 14Jan2021 13:00 for covid-19 immunisation.  Medical history included ongoing muscular dystrophy since the age of seven.  There were no concomitant medications. No additional vaccines administered on same date of BNT162B2. No prior vaccinations within 4 weeks. The patient experienced headache and feeling like have a cold on 21Jan2021 in first part of the day when he woke up, and has been feeling sick all weekend in Jan2021. He did not know if he had a fever. The events did not require a visit to Emergency Room or physician's office. No relevant test done. The outcome of headache and feeling like have a cold was recovering (also reported as ongoing), of feeling sick was unknown.  He was thinking about getting a test done, clarified as the quick COVID test, but he did not know if it will read a false positive. That is one reason why calling to determine if it would give a false positive.
Metallic taste in mouth; Left arm turned numb; Hives and rash; Whole body stayed numb for several minutes with mental confusion; not being able to speak properly; Blood pressure increased; This is a spontaneous report from a contactable other health care professional. A 26-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: ER8733), dose 1 via an unspecified route of administration, administered in left arm on 26Apr2021 at 15:15 (at the age of 26-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history reported as none. Concomitant medication was not reported. The patient was not pregnant at the time of vaccination. Patient did not have allergies. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. Facility type vaccine at hospital. On 26Apr2021 at 15:15, the patient experienced metallic taste in mouth 1-2 minutes from injection. 5-7 min after injection left arm turned numb, spread to left arm and rest of body. Hives and rash started developing on neck and face. Whole body stayed numb for several minutes with mental confusion and not being able to speak properly. Blood pressure increase. The patient underwent lab tests and procedures which included blood pressure measurement: increased. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treated in Emergency Room for allergic reaction. Adverse event treatment: Pretison, steroid, Benadryl and Pepcid. No COVID tested post vaccination. The outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Case received from a healthcare professional and forwarded by Crucell Vaccines, Inc.: A spontaneous report was received on 10.Jan.2012 and concerns a 32-year-old male patient who received VIVOTIF (batch number 3002144). The patient's medical history and concomitant medications were not provided. On 05.Jan.2012, the patient was vaccinated with Tdap, TWINRIX and flu vaccines. On 07.Jan.2012, the patient took the first dose of VIVOTIF. No adverse reaction was observed. On 09.Jan.2012, the patient took the second dose of VIVOTIF. Several hours later, he developed rash and hives on the arms and legs. The patient took BENADRYL and went to sleep. When he woke up the next day, on 10.Jan.2012, the rash and hives had cleared up. The case was considered non-serious.
Pt. received vaccine around 11:30. Slept in car seat and when in front pack 11:45-1:00. Nursed at 1:00 for briefer than typical time. Napped approximately 5 minutes before screaming. Inconsolable for 3 hours. Unable to nurse effectively at 3:00. Fell asleep again with maximum comfort techniques at 4:40. Woke herself up frequently with little squeals or screams. Back at dr. office at 5:00. Pt pale, lethargic, scream/cried at every change of position (e.g., held against parent chest vs. held cradled in arms). Pt. had worst reflux ever experienced, possibly due to intensity of crying. Given Tylenol by dr just after 6pm. Pt calmed, nursed well, still had difficulty with position changes. No fever. Started scream/crying again at 11 pm, still pale and lethargic. Given more Tylenol. Able to sleep 12-4am, able to nurse at 4am. Appeared tired and pale 11/14/13; closer to normal at 4pm.
A non-serious spontaneous report of a 61-year-old female given H1N1 Mist was received from a registered nurse concerning a 61-year-old female. The patient's medical history and concomitant medications were not provided. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event was considered resolved.
Pt complained of feeling ill, with chills, flushed face, injection site with erythema and induration. Temperature max of 103.1F. The next day (1/2/02), RN noted pt was lethargic, nauseated, pain at injection site with bright red and warm wheal 8cm X 6cm. Treated with ice packs and acetaminophen. Symptoms resolved within 7 days.
started on the date of vaccination, face and eyes were itching, throat closed up partially, tongue was prickly, lips were numb.  On 4/15/2021, went to urgent care .  abdominal and torso areas are itching, face is not and itching, tongues is prickly and lips are numb.   No breathing difficult but throat is red and swollen.
A couple of minutes after receiving a flu vaccine, Patient was sitting in a chair. RN and mom ehard a "thud" on the heater vent and patient was on the floor. Mom immediately picked him up and he started to cry. Mom believes his head hit the vent and floor. Patient was alert and oriented, answering questions appropriately. Ice was placed on his forehead. Mom thinks he looked like he passed out. RN did not witness the fall to to position in the room. Patient had a hematoma on his forehead.
2nd dose after 6 months; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient received 2nd dose of shingles vaccine after 6 months. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The follow up would not possible as no contact details were available.
Patient is calling to update her own adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient is calling to update her own adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 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 VACCINATION COMPLICATION (Patient is calling to update her own adverse reaction). At the time of the report, VACCINATION COMPLICATION (Patient is calling to update her own adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and medication information provided.  No treatment information provided
Patient called and stated that she is experiencing severe pains at the site of injection which started 3 days after the vaccine administration. She states that she has taken some over the counter antihistamines and pain medications. she stated that she also had acupuncture done twice in an attempt to relief the pain.
Burning, temperature change, color change, fatigue.  Predominately length-dependent but whole body involved at some point.  Suspect small-fiber neuropathy.  Steroid trial with probably no change.
Swollen arm, redness, hot Headache Chills Body aches Runny nose Sneezing
This consumer reports a possible exposure in utero. This female patient, age unknown started VARIVAX 1 vaccine on an unknown date in September 2013. The patient has no relevant medical history or concomitant medications. Her past drug history was unknown. On 20-DEC-2013, she had her menses that lasted until 23-DEC-2013. On 30-DEC-2013, she had another VARIVAX injection. On 17-JAN-2014 she had a blood test pregnancy that measured human chorionic gonadotropin 2-3 weeks. Also on 17-JAN-2014 she had an ultrasound showing the tubes were clear and a small sac but too early to see anything. As of 19-JAN-2014 it was unknown if she had her last VARIVAX on 30-DEC-2013 and she had a blood test pregnancy that measured human chorionic gonadotropin 2-3 weeks and an ultrasound showing the tubes were clear and a small sac but too early to see anything. She does not have the lot numbers or expiration dates of the VARIVAX. Additional information is not expected.
PATIENT SAID FIRST DAY WAS FINE, ONE DAY LATER ARM HAS 1 INCH X 1 INCH RED MARK AT INJECTION SITE THAT HURTS AND HAS "FEVER" IN IT.
Information has been received from a registered nurse at a day school, concerning a female child who, "in the past" was vaccinated with Varivax, and has subsequently been diagnosed with chickenpox. Unspecified medical attention was sought. There was no product quality complaint. No further information is available.