chrisvoncsefalvay/vaers-outcomes huggingface dataset:
AE with limited information; Sore arm; Felt a little tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (AE with limited information), PAIN IN EXTREMITY (sore arm) and FATIGUE (felt a little tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (AE with limited information), PAIN IN EXTREMITY (sore arm) and FATIGUE (felt a little tired). At the time of the report, VACCINATION COMPLICATION (AE with limited information), PAIN IN EXTREMITY (sore arm) and FATIGUE (felt a little tired) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow up received: Added patient demographics, doses information of suspect product and new events.
slight arm pain; localized in her injection site including itching and slight arm pain; localized in her injection site including itching and slight arm pain; acid reflux; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Lot number: GH9702, Expiration Date: 30Jul2023), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single), administration date: 25Feb2021, for COVID-19 immunization, reaction(s): "urine was cloudy and had a smell", "urine was cloudy and had a smell", "acid reflux"; Covid-19 vaccine (Dose 2, Manufacture unknown), for COVID-19 immunization, reaction(s): "Acid reflux", "her arms hurt for a good couple of months after the second COVID-19 shot"; Covid-19 vaccine (Dose 3, Manufacture unknown), for COVID-19 immunization, reaction(s): "arm pain"; Flu shot, for immunization, reaction(s): "arm pain"; Pneumonia shot, for immunization, reaction(s): "arm pain". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "slight arm pain"; VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "localized in her injection site including itching and slight arm pain"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "acid reflux".  Additional information: Patient stated that the only side effect that she experienced is a slight arm pain that was closer to the muscle locking rather than pain. Caller stated that in comparison to her flu shot every year, pneumonia shot and 3 other COVID shots, Caller described her symptoms as more localized in her injection site including itching and slight arm pain but also thinks it may be because she does physical therapy. Caller also stated that her arms hurt for a good couple of months after the second COVID-19 shot.Caller stated for the first time in her life she had no side effects. She called her doctor, and her doctor told her that it was normal and that some people do not get side effects. She is just concerned about the efficacy of the product. Caller has acid reflux.
Patient was nauseous, got up to get glass of water and fainted. Fell on bottom and then hit head. Went to Urgent Care and was referred to ER. Full evaluation and sent home. ER attributed reaction to Shingrix vaccine
Patient received, PENTACEL, ROTATEQ, Hep B and IPOL which should have been PREVNAR. I located the error after looking into the patient's chart at the vaccine record. I reported it to Dr. This happened on a Thursday and the patient had a follow up visit with us the next Thursday. Dr. and myself talked with the mother and told her of the mistake. There were no issues with the patient, no local reaction, no fever. The patient was given the PREVNAR and is now UTD. I wrote up the incident and the employee who made the mistake was counseled. Two MA's must check the vaccine prior to giving now.
Patient with area of left deltoid erythema with non discrete margins over the site of the injection. Occurred a couple of hours after injection. Approximately 24 hours after injection, still having very significant erythema, swelling, and pruritus requiring visit to clinic. Treatment with BENADRYL.
RECEIVED BOTH PFIZER COVID VACCINES ON 01/21/21 & 02/24/21. WENT TO ER ON 02/28/21 WITH COMPLAINT OF RIGHT SIDED NECK PAIN. DIAGNOSED WITH RIGHT SIDED CERVICAL STRAIN, ACUTE AND DEGENERATIVE DISC DISEASE. INSTRUCTED TO FOLLOW UP WITH SPINE CENTER.
After receiving the second dose, I experienced flu like symptoms (fever, aches, chills, weakness, and nausea).   After both my first and second dose, I started my period on the same day that I received the vaccine. My period was on time but, different. The colour of blood seemed off, looked diluted in a way, and I had EXTREME cramping which is abnormal for me. At one point I felt as if I was having contractions. The extreme cramping occured the following day after receiving my vaccines. It has been 36 hours since my second dose and the symptoms are subsiding.
Within 5-10 minutes of receiving the vaccine my heart starting racing a little bit, I got a little light headed, and had a weird taste in my mouth. The morning after my vaccine (1/22/2021) the Injection site of the vaccine is swollen, hot to the touch, and red/hard. The following day (1/22/2021) around 3:45 pm I broke out in a rash on my face and neck
Pt had redness and tenderness in arm. Advised to use benadryl and tylenol
Systemic: Neurological Disorder (diagnosed by MD)-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Additional Details: Patient diagnosed with syndrome of facial paralisis bell. Doctor prescribed prednisone, acyclovir. Doctor said it will resolved in a week
Patient presented to Hospital Emergency room with fever, compalin of chills, shaking, dizziness, abdominal pain and vomiting.  12/26/2008 ER record received 12/02/2008 with DX: Fever s/p immunizations. Pt presented with c/o general malaise, back pain and nausea since immunizations. PE (+) for suprapubic tenderness and bilateral CVA tenderness, T=102.0. Given IVF bolus, Zofran and Tylenol. Pt felt better and d/c
Pt had hives at injection site.  Pt complained of itching.  Reported adverse effects to health dept.  Pt parents & teacher notified.  If hives worsen pt to report to teacher.
Hard lump at injection site noticed this evening while changing her diaper. It is red. Seems to be tender and to cause discomfort.
Narrative: Patient is a 74 year old MALE who received the 1st dose of COVID vaccine 3/3/21. Spoke w/pt today RE: adverse reaction related to the vaccination. ------------------------------------------------------------------------- SYMPTOMS: Fever No If yes temp: n/a Fatigue No Myalgia No Arthralgia No Rash/Hives No SOB No Bell's Palsy No Injection site Reaction Yes Other No If yes describe: tenderness in arm x2 days
inadvertently administered the Pediarix after the temperature excursion; This case was reported by a nurse and described the occurrence of incorrect product storage in a 6-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 7P2Y3, expiry date 8th April 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th November 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 17th November 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were reported as follows: This case was reported by the Licensed Vocational Nurse. She stated that, they inadvertently administered the Pediarix after the temperature excursion to the patient in the left Vastus Lateralis, which led to incorrect product storage. The vaccine was exposed to 11.8 Fahrenheit 56 minutes. No Prior excursions. The reporter did not consent to follow up. This case has been linked with US2021AMR238664, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR238664:same reporter
Mom reports pt screaming for 3 hrs straight with approx 5 min breaks from screaming to sleep, right leg with swelling. Tylenol 0.4ml given q 4 hrs since just before vaccine cool compress to legs.
Swelling, redness, warm to touch at site extending approx. Spoke with patient on 6/26/12 and site is better less swelling and pain, not completely gone yet.
Started with oral typhoid 1/3/07 became nausea. On 1/5/07 took pill #2 vomited pill up, felt very nauseous after 7 hours and then on 1/06/07 noticed rash on lower lip itchy red and raised went to ER.
Severe body ache, especially calf muscles,  chills, head ache, exhaustion injection site pain including shoulder and shoulder blades.
Received An Expired Dose of Heplisav-B; Initial Report Received on 04-Nov-2022  This is a spontaneous report, received from a nurse regarding a male patient, aged 60 years, who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.   Concomitant medications were not reported.  On 31-OCT-2022, an unspecified dose of HEPLISAV B (Lot #935842, expiration date 29-OCT-2022, NDC #43528-003-05), route not specified, was administered in right arm for hepatitis B immunization.    The patient received an expired dose. The patient did not report any adverse reactions.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Local redness and swelling times 2 days. S/P 2nd pneumococcal vaccine
Pain and spasms in both legs, overall pain in arms, legs, back. Occured immediately after 1st dose and continues to date.
pt got his second Covid 19 vaccine yesterday am 2/3/21 at 7:30 am.  She says last night at about 7:30 pm he started feeling bad.  She says his s/s have continued into today having a temp of 99.5 to 103, body aches, headache, chills.
Vaccine error. The patient received Dose 1 Pfizer 2/27/2021( (lot # EN6202) and received a second dose of Moderna (llot 032M20A) in error. The dose should have been Pfizer and the timing should have been after March 16. The error occurred in part because the patient self-selected to return prior to the appointment date, and did not have his vaccine card at the time of dose #2. The event occurred at a large vaccine site administered jointly  .  A site review was conducted to quantify errors and tighten processes. This event is being reported as a vaccine err to assist in data collection and process improvement.CDC recommendations are that no further action is needed at this time.
54-year-old male brought in code 3 for acute respiratory distress and chest tightness. EMS stated that they spoke with the wife who noted that the patient had been having some trouble breathing for the last few nights with chest tightness intermittently but had not had any known significant illness. Patient does have a history of hypertension. When patient was first found he was significantly hypoxic into the 80s and attempts were made to provide oxygen for the patient but he was fairly agitated and a bit delirious having difficulty with both CPAP as well as facemask and nasal cannula flow repeatedly trying to remove the delivery devices. He apparently was complaining of shortness of breath and chest tightness but history is otherwise difficult to obtain. EKG was obtained which showed a diffuse amount of artifact and some nonspecific precordial changes concerning for the possibility of cardiac process but not clearly demonstrating ST elevation given artifact. He was transported here on arrival unable to provide history with fairly rapid decompensation due to cardiac arrest.
had a breakthrough infection; This is a spontaneous report from a contactable consumer or other non hcp.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on 18Aug2021 the patient experienced had a breakthrough infection. Outcome of the event was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
24 hrs after receiving vaccine became very itchy on chest and arm. 28 hrs after, arm became swollen and red & warm. 36 hrs. after became itchy everywhere. Some red areas. Took BENDARYL after calling Doc. Symptoms went away 8-12 hrs. later.
Severe depression; Had no appetite; Slept most the day; Felt very fatigued; Mild soreness in the same right arm; This spontaneous case was reported by a pharmacist and describes the occurrence of DEPRESSION (Severe depression), DECREASED APPETITE (Had no appetite), SOMNOLENCE (Slept most the day), FATIGUE (Felt very fatigued) and MYALGIA (Mild soreness in the same right arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     The patient's past medical history included Exposure to mold (Exposed to black mold) and Solid organ transplant. Concurrent medical conditions included Type 2 diabetes mellitus (Type 2 diabetes on medication) and Asthma.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced DEPRESSION (Severe depression), DECREASED APPETITE (Had no appetite), SOMNOLENCE (Slept most the day), FATIGUE (Felt very fatigued) and MYALGIA (Mild soreness in the same right arm). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Adverse drug reaction, at a dose of 1500 mg. At the time of the report, DEPRESSION (Severe depression), DECREASED APPETITE (Had no appetite), SOMNOLENCE (Slept most the day), FATIGUE (Felt very fatigued) and MYALGIA (Mild soreness in the same right arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.    This case was linked to MOD-2021-302002, MOD-2021-301965 (Patient Link).
Red indurated area around shot area. 5.5X3.5 cm. No drainage. Not painful.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 13:15 as dose 5 (booster), single (Lot number: Gh9702) at the age of 62 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Mar2021 as dose 1, single (Lot number: 002A21A), in left arm, on 31Mar2021 as dose 2, single (Lot number: 007B21A), in left arm, on 24Nov2021 as dose 3 (booster), single (Lot number: 033F21A), in left arm and on 22Jul2022 as dose 4 (booster), single (Lot number: 017B22A), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient has no known allergies. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken (Paxlovid) as a result of drug ineffective, covid-19.
Client complained of discomfort when vaccine injected from vaccine not the needle stick.  Within 30 minutes presented with arm at site of injection red/swollen/warm with redness radiating up shoulder and neck. No SOB at this point. BP132/84. Benedryl 50mg IM in opposite deltoid and cold compresses applied to injection site.  Fifteen minutes post Benadryl complains of nausea/dizziness,slight SOB sensation. BP120/82 P88; redness on neck reduced in size/color. Unable to locate family to transport client, PMD called and advised EMS transport. Approx. 70min. after injection client transported to hospital. Redness in all sites reduced and site swelling slightly reduced.  Follow-up conversation on 11/26/03 with client who reports spent several hours in ER due to fluctuation in BP. Received IV fluids while there. Seen two days after incident in PMD office; was advised not to take flu vaccinations in the future. Client reports slept most of weekend after vaccination which is out of ordinary for her.  Returned to work on 11/24 still feeling fatigued.  However, by time of follow-up conversation was feeling fine.
Booster shot. per patient, she had an existing scab at vaccination area, pharmacist that gave the shot went through the scab and now patient has red, localized and inflamed bruise that is about 3  inches big.  Pt said she noticed it the morning of the shot. Pt will go see md and has appt on 11/23. Pt said she is feeling fine and that it was itching for a bit.
Soreness on arm on the way home/arm hurt; pain increased yesterday, last night felt horrible, hurt from head to toe/ She hurt all over; pain increased yesterday, last night felt horrible, hurt from head to toe; Major chills; bad headache; feel mucous going down her throat/she is having drainage that is going down her throat; flu; fever; felt like she was going to give out; joint pain; This is a spontaneous report from a contactable consumer (patient) or other non HCP via medical information team.   A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown, Expiration date: unknown) via an intramuscular route of administration in left arm on 06Feb2021 at 13:00 (age at vaccination 70-year-old) at dose number unknown single for covid-19 immunisation. The patients relevant medical history included she has a slow metabolism She said that she has a lot of reactions to medications because her metabolism is so slow, Covid-19 in Mar2020 and was out for about 6 weeks. The patients concomitant medications were not reported. On an unspecified date in feb2021 patient experienced Soreness on arm on the way home arm hurt, pain increased yesterday, last night felt horrible, hurt from head to toe, Major chills, headache, feel mucous going down her throat she was having drainage that is going down her throat, flu, Fever, felt like she was going to give out, joint pain. She was hurting that she had like a major flu. She said that she had a lot of reactions to medications because her metabolism is so slow. She said that maybe a hour or so ago, she took a tramadol and reported that she did have a fever. her fever is now going down. patient was supposed to go back on the 27Feb2021 to get her second dose of the vaccine. The patient underwent lab tests and procedures which included COVID-19 SARS-CoV-2 antibody test: Negative on an unspecified date. The outcome of events was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts completed. No further information expected.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L017407, expiry date 15-AUG-2017; lot # L013429, expiry date 21-JUL-2017) (dose, route and dose number were unspecified). No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.
Information has been received from a physician, a medical assistant and the patient's mother concerning, a 15 year old female with no medical history or drug reaction/allergies reported who on 19-APR-2010 was vaccinated with a dose of GARDASIL (lot n. 663573/0969Y), 0.5 mg.  Concomitant therapy included LOESTRIN.  The patient's mother stated that her daughter was given GARDASIL on 19-APR-2010, and this date, she "jerked" within 20 seconds and then she passed out and her blood pressure dropped precipitously.  She came to and had nausea and tenderness at the injection site.  She started feeling dizzy and had a 102 degree fever for 4 hours.  Her extremities started tingling and she had diarrhea on days 3 and 4 following injection, and she had fatigue for first 72 hours.  At the time of reporting, the patient still had bouts with dizziness and nausea and she passed out again on 03-MAY-2010.  On 04-MAY-2010, the patient experienced headache.  Subsequently, the physician stated that the patient received the first dose of GARDASIL and experienced syncope with seizure like movement of the arms and legs about 15 seconds.  Physician felt as though it is related to GARDASIL.  Later, the medical assistant reported that the patient experienced syncope then, tonic clonic movements.  She stated that the physician did not feel this was a seizure (conflicting information with physician's information).  The event was not disabling or life threatening and patient did not need to go to the emergency room.  Treatment included an antiemetic and increased fluid intake.  At the time of reporting the patient was still recovering.  Upon internal review syncope with seizure like movement of the arms and legs was considered to be an other important medical event.  Additional information has been requested.
Vaccine expired in refrigerator on 9/25/2021. Vaccine administered on 9/26/2021 (vaccine stable undiluted in the refrigerator on-label for a duration of 31 days, 9/25/2021 would have been the 31st day). Vaccine was not pulled from the refrigerator the day it expired on 9/25/2021, hence accidental continued use by another pharmacist on 9/26/2021. Pfizer reported, based on physical stability data, there is an extended excursion time of +1 day for a total stable undiluted refrigerated time of 32 days, but to still file reports due to off-label use.
Information has been received from a registered nurse concerning a staff worker who in approximately 2000 was vaccinated with a series of Recombivax HB (manufacturer unknown) and was not immunogenic.  Subsequently the patient experienced no adverse symptoms.  It was unknown whether medical attention was sought.  There was no product quality complaint.  Follow-up information indicated that the staff worker did not get her immunizations in the office or by the office.  Titers are rechecked on every employee and she was not immunogenic.  No further information is available.