chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg)); This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg))) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg))). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg))) 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 assessment was provided for INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg))).    No concomitant medications were reported.   Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022.  It was reported that the patient had received 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose.   It was unknown if patient experienced any symptoms after getting the vaccine.  The reporter was told that adult patients who received a 25 mcg dose in the past 24 hours could come and get another 25 mcg dose and be considered as getting a full 50 mcg to start with, but it was reported that the vast majority of patients had received this half dose more than 24 hours ago.  No treatment medications was provided by the reporter.
This is a spontaneous report from a contactable consumer. A patient of unspecified age ethnicity and gender received meningococcal group B (unknown if Trumenba or Bexsero), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction on an unspecified date with outcome of unknown. Follow-up (27Sep2016): New information received from a contactable consumer includes: reporter's address updated. Pfizer is Marketing Authorization Holder of meningococcal group b rlp2086 in the reporter's country. This may be a duplicate report if another Marketing Authorization Holder of meningococcal group b rlp2086 has submitted the same report to the regulatory authorities.
Patient presented in employee Bivalent vaccine COVID clinic. Patient may have received a dose of monovalent COVID vaccine during clinic. Unable to determine if patient received monovalent or bivalent vaccine.
This case was reported by a pharmacist and described the occurrence of headache in a 16-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 14 June 2011 at 09:20 the subject received 1st dose of BOOSTRIX (.5 ml, unknown route, left arm). On 14 June 2011, 5 to 10 minutes after vaccination with BOOSTRIX, the subject experienced headache and blurred vision. On 14 June 2011, the events were resolved. The pharmacist considered the events were possibly related to vaccination with BOOSTRIX.
Dizziness, Headache, Myalgia, Fever, Angioedema, NauseaVomiting, injection site pain, breast tenderness Narrative: Employee reports onset of symptoms as "immediately after vaccine administered." Reports injection site pain, fever (100.1 F), headache, body aches, dizziness, nausea, fatigue, low back pain, bilateral breast tenderness. Also reports "itchy face, mouth numbness, throat swelling (without dyspnea/dysphagia)" which lasted <1 hour. Reports called in sick to work x 2 days. Reports starting to feel better as of date of this report, but is not yet fully recovered. Advised to notify PCP of facial itching oral numbness, and throat swelling prior to receiving 2nd dose. Employee stated she does not have a PCP. Reports us of Tylenol x 1 dose.
Client pregnant - PHN missed reading yes to pregnant on screening questionnaire and she received VARICELLA vaccine.
EXPIRED VACCINE IS ADMINISTERED DUE TO MISUNDERSTANDING WHEN STABLISHING THE EXPIRATION DATE IN THE PREIS REPORT.
After applying the DTaP, MMR, POLIO, VARICELLA vaccines, to be more specific, on day number four, my four year son woke up with the left side of his face swollen with severe pain and with swallowing problem. And to make it worse a week later the same thing happened to the right side. It should be mentioned during this days he could not eat or drink anything.
shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Heart disease, unspecified since 1994. Concomitant products included RIVAROXABAN (XARELTO), VALSARTAN, SOTALOL and ROSUVASTATIN for an unknown indication.    On 26-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced HERPES ZOSTER (shingles) (seriousness criterion hospitalization). The patient was hospitalized from 03-Feb-2021 to 04-Feb-2021 due to HERPES ZOSTER. On 01-Apr-2021, HERPES ZOSTER (shingles) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment also included Acyclovir. The patient described the adverse event as "a rash with blisters, very itchy and painful". The patient received their second dose of mRNA-1273 (Moderna COVID-19 Vaccine; batch no. unknown) (Intramuscular) 1 dosage form on 04-Mar-2021 at 1:00 PM, and no adverse events were reported at the time of the report.  Company Comment : This case concerns a 78-year-old male with a serious unexpected event of herpes zoster. Latency 8 days after first dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Case upgraded via VAERs form received which listed hospitalization for event; Patient race, history, Suspect drug dosage details, concomitant drugs details; Sender's Comments: This case concerns a 78-year-old male hospitalized with a serious unexpected event of herpes zoster. Latency 8 days after first dose mRNA-1273. Event resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-JAN-2019, the patient was vaccinated with improperly stored VARIVAX, lot # R022116, expiration date 02-AUG-2020, subcutaneously, diluted in properly stored sterile diluent for prophylaxis. The vaccine was stored in temperature ranges 15 Fahrenheit degrees to 46 Fahrenheit degrees for 45 minutes. Previous temperature excursion was also reported in ranges 6 Fahrenheit degrees to 14 Fahrenheit degrees for 30 minutes and 15 Fahrenheit degrees to 46 Fahrenheit degrees for 8 hours and 5 minutes. The temperature was measured by "data logger". No adverse effects reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1902USA000278; US-009507513-1902USA000279.
Pain, fever first noted @ 630PM; temp measured at 103; Seen in ER by MD: Tx Trimox & Dimetane;
On the 8th day after shot I started getting pain under left armpit. The pain became worse over the next several days resulting in what I'd describe as an electrical shock/burning feeling whenever I moved my left arm the wrong way (seemingly pinching the lymph nodes). I'm currently on day 5 of the pain and it's still present although it has lessened on the 5th day. On the 2nd day the pain started to move down from the armpit closer to the pectoral.
Delayed reaction:  vaccine administered on 4/4/03.  Patient woke up on 4/11/03 with swollen L arm with redness and questionable shortness of breath.
After receiving the pneumonia vaccine, I felt woozy.  I felt better and went home.  Saturday morning, 10/10/2009, I woke up with a silver dollar sized welt on my arm around the injection site.  I continued to feel off and woke up Sunday morning, 10/11/2009, with a welt the size of a fist on my arm, and severe joint and muscle pain.  I was told by on call at the hospital to go to the ER.  I was kept in the ER for 24 hours.  The welt, by that time, had doubled in size, nearly spreading from my shoulder to my elbow.  I was admitted to the hospital the afternoon of Monday, 10/12/2009.  I was treated with IV antibiotics and was released from the hospital the evening of Tuesday, 10/13/2009.  I was diagnosed with cellulitis, an infection, and was sent home with oral antibiotics.  There is some question as to whether the vaccine was administered correctly, as it was not given in the muscle of the arm and was instead given in the soft tissue..I presented in the ER with fever, elevated white blood cell count, swelling from the shoulder to the elbow, severe pain and loss of mobility. I was told by rheumatologist that I needed to receive a pneumonia vaccine due to my being immunosuppressed.  This was suggested given all of the medications I am on for lupus and rheumatoid arthritis.   10/2602009 Discharge summary and medical records received for DOS 10/11-10/15. FINAL DX: Left upper arm cellulitis, possible arthus reaction to Pneumovax: Patient presented in ER with red rash and swelling L upper arm s/p vaccine. Area with warmth and throbbing. Position dependent pain, swelling. affected area increased from 2cm area to 12x8cm area by day 2. Movement painful. Chills. Also aching leg pain. Temp 38.4. WBC increased. Affected area increased in spite of ABX therapy in ER. Admitted for continued ABX therapy and Benadryl.  Affected area reduced by next am.  Discharge to home. Follow-up with PCP noted resolved. 11/9/09:  Discharge summary and medical records received for dates of service 10/11/09 to 10/13/09.  Final DX:  Left upper arm cellulitis, possible arthus reaction to Pneumovax.  No additional information.  11/9/09:  ICD 9 codes received:  682.3, 710.0, E948.8, 714.0, 311, 530.81
This spontaneous report as received from an office manager refers to a patient of an unknown age and gender. The patient's current conditions and medical history were not reported. On 25-OCT-1999, the patient was already vaccinated with PNEUMOVAX23 injection (unknown strength, route and dose). On 29-MAY-2015, the patient was supposed to get vaccinated with PREVNAR 13 but instead was vaccinated with PNEUMOVAX23 by a "floating" nurse. The outcome of the event was unknown. There was no product quality complaint involved. Additional information is not expected as no healthcare professional contact details were provided.
Parathesis, brain lesions, possible multiple sclerosis. Symtoms still ongoing. Treatment catscan, MRI, and spinal tap. Information from medical records states decreased strength. msv
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: EL8982), in left arm, on 01Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 19Nov2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma/restrictive airway" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received other medications in two weeks (ClaridinD, Proair, Symbicort, Flonase allergy) from 30Apr2022 to 25May2022 and had no known allergies. Patient was treated with Paxlovid from 10May20222 to 15May2022 for treatment of Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had a case of COVID-19, I had a fever when I woke up in the morning. I had chill and did not have an appetite, fatigue, and a mild cough. I was short of breath and went to the doctor. I went to the doctor and had an instant test for COVID-19 and tested positive. My fever subsided after 24-hours but I still felt fatigued and short of breath. After 5 days, I went to the doctor again and had another instant test for COVID-19 and tested positive again. After, 3- months I started feeling back to normal.
Severe arm edema 8" by 6", red, hot to touch, irritation at injection site above, symptoms lasted 6 days.
Severe pain in upper arm near shoulder and radiating down arm, which has gotten worse.  Extremely tired last 3/4 days.
Patient under age 18 was vaccinated with Moderna, which is a vaccine error.  Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn her away on a Moderna-only day. Unreported as error, found in data mining. This vaccine was given  before an ID/verification of birthdate requirement was put into place.  Second vaccine was also not reported although allowed per agency and CDC standing orders.
My son has been dealing with unexplained hives that have lasted for months. He gets them every night. He has been on steroids but it is not helping. Finally, the doctors said that most likely due to the covid vaccine. Covid vaccine. Second dose
Cellulitis type reaction (redness, erythema) starting injection site to elbow area.
8/24/21   -11:58 pm Hives located on buttocks, lower belly, arms, and underarms; tightness of chest accompanied by dry cough which persisted for approximately 30 minutes.  Symptoms were relieved with Benadryl and Calamine lotion.   8/25/21   10pm-11pm -  reappearance of hives on buttocks, lower belly, underarms, dry cough, swollen eye, tightness of chest.  Symptoms subsided 30 minutes following a dosage of benadryl.  8/26 /21   3pm  - Hives   08/27/21- 10:30 PM  Hives on the legs, inner thighs, neck, arm, buttocks, underarms, around lips, itchy/watery eyes, tightness of chest, dry cough.
the next day after shot,  had a sore red arm, swollen and hot to touch.     lasted for over a week.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 21-DEC-2015, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
feeling like he has shingles in his whole body; severe muscle / pain; joint pain / right shoulder / aching; pain is excruciating / disabling / "jumps around a little bit," / going on for almost a month / still ongoing; his head / aching; intense pain / to both legs / right arm / aching; right kidney "feels like there is a knife in it" / new shooting pain; intense pain from the testicles; is having to wake up every couple of hours to take pills; This case was reported by a consumer and described the occurrence of shingles in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 29th December 2020, 3 days after receiving Shingrix, the patient experienced shingles, muscle pain, joint pain, general body pain, headache, leg pain, renal pain, testicular pain and poor sleep. The patient was treated with naproxen (Aleve), ibuprofen, prednisone and naproxen. On an unknown date, the outcome of the shingles, muscle pain, joint pain, general body pain, headache, leg pain, renal pain and testicular pain were not recovered/not resolved and the outcome of the poor sleep was unknown.   It was unknown if the reporter considered the shingles, muscle pain, joint pain, general body pain, headache, leg pain, renal pain, testicular pain and poor sleep to be related to Shingrix.  Additional details were reported as follows: The patient received the vaccine in the upper left arm. The patient experienced severe muscle and joint pain after receiving the vaccine. The pain started 2 to 3 days after getting the vaccine.  He stated that the pain was excruciating and disabling.  He had intense pain from the testicles down to both legs.  He stated that the pain "jumps around a little bit" but reported his head, right shoulder and right arm were aching at the time of report.  His right kidney "feels like there was a knife in it" and it was a new shooting pain as of yesterday that was on the right side of the body and both legs.  He waked up every couple of hours to take pills.  He stated he had taken more ibuprofen and naproxen in the last 20 days than he had in his whole life.  He had taken 2 pills of Aleve every 8 hours and had been given prednisone to knock out the pain.  He reported that the Aleve was "only knocking half of it out unlike before".  He felt like he had shingles in his whole body.  He reported being healthy, but the pain had been going on for almost a month and was ongoing The reporter did not consent to follow-up.
Dizziness- started 4/17/2021, and has been on-going. Second dose received 4/14/2021.
Severe stomach pains on 07/17/13 which subsided for a while and would come and go until severe pains 8/27/2013 and appendicitis on 8/28/2013. Also has experienced hair loss since Sept 2013.
Syncope was observed; This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for 3 patients. This is third of 3 reports.  A male patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced syncope was observed on an unspecified date between 6 months and 12 months ago. Event took place after use of product. The outcome was unknown.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 contributed to the development of the reported event syncope.,Linked Report(s) : US-PFIZER INC-2019217296 Same reporter/drug/event, different patient;US-PFIZER INC-2019217420 Same reporter/drug/event, different patient
Seen in Immediate Care on 12/12/2021: Patient presents with rash on bilateral lower legs. Patient states she received her COVID booster 4 days ago. She had fever, body aches, and severe fatigue. Those symptoms have now all resolved. Patient states she noticed the rash this morning when putting on her socks. She has no other symptoms. Patient states she did not have any side effects from the first two doses of the vaccine. She denies chest pain, shortness of breath, bleeding from gums, tachycardia, palpitations; On 12/13/2021 lab work confirmed Thrombocytopenia  diagnosis.
Began getting rash - all around my waist like needle pin joint rash and itch terribly.  Then spread all over my stomach and groin area - still have it on my trunk of my body, on my neck, arms - have them still treating it twice daily with Lotrisoni CR 2%.
Headache, Fever, Diarrhea, chills, fatigue Narrative:
COVID vaccine breakthrough case. Moderna 3/4/21 030A21A, 4/1/21 017B21A, and boosted 11/1/2021 939906
Experiencing similar symptoms now as I did the after receiving the second dose April 17th. That is headache, chills, fatigue, some nausea, however, no fever
After the first shot I began feeling weak and achy all over, from my head to my feet. I was hobbling the pain was so bad. The palms of my hands hurt, my legs, my arms. It was very scary and I was in near tears. The next morning I called doc services and the doctor said to be seen by a doctor to check my white blood cells. (My physical shows all my numbers are normal every year). I went to urgent care about 11 am and he said because I didn?t have a fever there wasn?t need for concern. He prescribed methylprogesterone. Since that said to start in the morning, I simply took ibuprofen. By the next morning I was feeling better and did not take the medication.  For the second shot, I pre-medicated using the prescription I didn?t use the first time. The pain was nominal about four hours post shot and I almost finished that. The last two days however, I have had constant noticeable heart palpitations. Although I was told years ago I had a heart murmur it has not affected me, so this was puzzling then I read the pkg insert saying if this happens just after the shot to contact the doctor. Since this shot was given on Sunday 9/29/19 at 2:00pm I didn?t think this was just after. If it persists I?ll contact my doctor.
Sever stomach pains resulting in 24 hours of diarrhea and vomiting; 24 hours of diarrhea and vomiting.; 24 hours of diarrhea and vomiting.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 21Apr2021 at 07:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 24Apr2021 at 22:00, the patient experienced sever stomach pains resulting in 24 hours of diarrhea and vomiting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the events sever stomach pains resulting in 24 hours of diarrhea and vomiting was not recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
I started feeling achy (body aches) at night and took Tylenol and the next day at work I started having abd pain, joint pain and headache, and at home I checked my temp and it was 100.8F and my heart rate was fast, my lungs felt tight and a Tylenol and the symptoms continued for another day and gradually went away with exception of my joint pains. I also had tingling on my arms, back of my head, legs and my neck. I went to a neurologist and an allergist . My PCP does not want to make a decision about whether or not I should have the second dose before I see those.