chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A sudden cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: CARDIAC ARREST (medically significant), outcome "unknown", described as "A sudden cardiac arrest".  Clinical information: Reporter states that her husband had a sudden cardiac arrest a few days after getting his second Pfizer vaccine. He lived but 90 percent of people who have these do not.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Booster dose of 0.25mL of Moderna Covid-19 vaccine that was out at room temperature for 24 hrs was given to one of our patients; Booster dose of 0.25mL of Moderna Covid-19 vaccine that was out at room temperature for 24 hrs was given to one of our patients; 2nd dose: 27Jan2021, 3rd dose: 07Jan2022,4th/booster dose: 04Feb2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose of 0.25mL of Moderna Covid-19 vaccine that was out at room temperature for 24 hrs was given to one of our patients), PRODUCT STORAGE ERROR (Booster dose of 0.25mL of Moderna Covid-19 vaccine that was out at room temperature for 24 hrs was given to one of our patients) and EXTRA DOSE ADMINISTERED (2nd dose: 27Jan2021, 3rd dose: 07Jan2022,4th/booster dose: 04Feb2022) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose of 0.25mL of Moderna Covid-19 vaccine that was out at room temperature for 24 hrs was given to one of our patients), PRODUCT STORAGE ERROR (Booster dose of 0.25mL of Moderna Covid-19 vaccine that was out at room temperature for 24 hrs was given to one of our patients) and EXTRA DOSE ADMINISTERED (2nd dose: 27Jan2021, 3rd dose: 07Jan2022,4th/booster dose: 04Feb2022). On 04-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Booster dose of 0.25mL of Moderna Covid-19 vaccine that was out at room temperature for 24 hrs was given to one of our patients), PRODUCT STORAGE ERROR (Booster dose of 0.25mL of Moderna Covid-19 vaccine that was out at room temperature for 24 hrs was given to one of our patients) and EXTRA DOSE ADMINISTERED (2nd dose: 27Jan2021, 3rd dose: 07Jan2022,4th/booster dose: 04Feb2022) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was given as 03-FEB-2022 Date vial moved from freezer to refrigerator was mentioned as 03-FEB-2022 Proposed desired Use by Date was given as 03-FEB-2022 Excursion duration-12 hrs. (greater than 24 hrs.)
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 for prophylaxis. Other suspect therapies included PEDVAXHIB. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered no adverse event to be not related to GARDASIL 9 and PEDVAXHIB. The reporter considered incorrect product storage to be not related to PEDVAXHIB and GARDASIL 9.
At  6 hours after shot, I developed fever to 101, sever chills, body aches, joint pain, my skin hurt, headache and extreme fatigue. This lasted for 24 hours resulting in loss of work the next day. Then 6 days later, I am still tired and achy, have soreness in my upper arms, and have a severe headache.
Severe headache, fever, chills, muscle aches, injection site pain, fatigue.
A hours after receiving injection paitents arm became very swollen, red and painful about 2" below where shot was given extending to elbow.  Called me at home the next day to report-advised ibuprofin and heat as swelling had decreased but still c/o pain.  I called 11-12-03 and patient said arm was much improved did not seek medical attention.
This case was reported by a other health professional via call center representative and described the occurrence of pain in a 41-year-old male patient who received SHINGRIX (batch number 7X3EJ, expiry date unknown) for prophylaxis. Co-suspect products included SHINGRIX (batch number 4LP5Y, expiry date unknown) for prophylaxis. The patient had a Family History of shingles (patient's cousin had shingles). Concurrent medical conditions included allergy to plants, grass allergy and allergy to animal dander. Concomitant products included Flu unspecified (Flu vaccine). On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st August 2018 02:18, the patient received the 2nd dose of SHINGRIX (intramuscular). On 1st November 2018 08:00, not applicable after receiving SHINGRIX and 92 days after receiving SHINGRIX, the patient experienced pain and adverse event. On an unknown date, the patient experienced off label use. On an unknown date, the outcome of the pain, adverse event and off label use were unknown. It was unknown if the reporter considered the pain and adverse event to be related to SHINGRIX. Additional details were provided as follows: It was reported that the patient's cousin had shingles at age of 35, so the patient dose of SHINGRIX at age of 41 years old, this led to off label use of product. In 2018, the patient had blood test, computerised tomogram scan (CT) and Nuclear magnetic resonance imaging (MRI), results were not provided. The patient experienced severe adverse events after receiving SHINGRIX. The reporter consented to follow up.
Itchy rash, started on legs, now all over body. Sx started 5/16/15.
Information has been received from a RN concerning an 8 yr old male who on 26Aug98 was vaccinated with a dose of varicella virus vaccine live. On 22Dec05 the pt developed a rash, fever and less than 50 lesions that were red papulovesicular in nature and on his trunk, scalp and arms. The pt was seen by a physician and diagnosed with a mild case of varicella. Subsequently, the pt recovered. No product quality complaint was involved. No other information provided. Additional information is not expected.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with an unspecified number of doses of improperly stored PROQUAD (dose and route unknown, lot # M009746, expiration date: 23-AUG-2017) for prophylaxis. The vaccines were stored in -11.2 degrees Celsius for 15 hours 20 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA000601.
The evening of the vaccination, she was normal. The next morning when my sister woke up, our mother's legs were stiff and halfway off the bed. She couldn't move them. She could not fully use her arms either. From that moment, she was never able to get out the bed again. For the next two weeks, she was in and out of consciousness and we began planning her funeral. Nearly three weeks after the vaccination, she awakened somewhat for about two or three weeks. She died October 3, 2021. Our mother had been in hospice care to ease the burden of traveling to doctor appointments for the prior few months. Because of their care goals, there was no treatment of symptoms given, except for recommendation of pain medicine.
Healthy athletic male with no history of ear/vestibular issues. Received Pfizer booster and flu vaccine together. Typical inflammatory symptoms occured and resolved after 24-36 hrs, as is typical for pt.  However, 5 days post-vaccination he had onset of  dizziness, disequilibrium, and vertigo.  These continued and when seen by physician on day 14 post-vaccination, prominent bilateral middle ear effusions were seen.  Medical treatment plan initiated.
Hives on arms and neck on May 3 in the afternoon. About 48 hours after vaccination. Started warm compresses and BENADRYL, which stopped progression of hives. No airway, lip, tongue involvement. No respiratory distress.
Patient received expired influenza vaccine (exp 6/30/2022). Patient notified of event and need for repeated vaccination with 2022-23 Seasonal vaccine.
This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information received as follows: This was reported previously to manufacturer. The age at vaccination was not reported. The pharmacist reported to the Field Representative the day before reporting that the patient who was relative of hers recently received the SHINGRIX vaccine and developed flu-like symptoms that lasted 2 to 3 days. It was unknown what vaccine in the series it was or the exact date of the adverse event. No Product Quality Complaint (PQC) was filed.
This spontaneous report was received from patient's father concerning his daughter, a female patient of unknown age. Patient's concurrent conditions and relevant medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. On an unknown date the patient experienced complete hair loss after receiving GARDASIL. The outcome of complete hair loss was unknown. The causality of the events with GARDASIL was not reported. Additional information has been requested.
Lymph node under arm pit swollen and painful for over 24 hours. Same arm as injection site.
given ACT-HIB on 13Oct2023, but the vaccine was already 6 days past its expiration date (with no reported adverse event); Initial information received on 13-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old female patient who was given act-hib on 13oct2023, but the vaccine was already 6 days past its expiration date (with no reported adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine live reassort oral 5V (Rotateq), diphtheria vaccine toxoid, hepatitis B vaccine RHBSAG (yeast), pertussis vaccine acellular 3-component, polio vaccine INACT 3V (vero), tetanus vaccine toxoid (Pediarix) and pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) for Prophylactic vaccination.  On 13-Oct-2023, the patient received 0.5 ml (dose 1) of suspect HIB (PRP/T) VACCINE, Powder and solvent for solution for injection lot UJ784AA, expiry date: 07-Oct-2023 via intramuscular route in the left thigh for immunization (strength: unknown) but the vaccine was already 6 days past its expiration date (with no reported adverse event) (expired product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
breathig issues, fast heartbeat, diziness, weakness, tiredeness, headache, muscle pain, joint pain,naseau, decreased appetite,fainted
In the evening, I guess around 9 p.m., after I filed last report  vac site started itching with pain and hardness and swelling in area around shot site, that had practically disappeared over previous two days, suddenly increased a lot (on your scale it would be halfway). At 3 am March 11 the itching was so severe it woke me (would be near the top of your scale). Also an arthritis reaction Type 3 delayed serum allergy was quite noticeable in joints. I took Benadryl and an hour later a prednisone tablet from a bottle that expired three years ago. Neither symptom worsened after that and were better in the morning and diminished over the next couple of days. Except the following two evenings the significant itching around vaccination site returned around 9 pm (but not as bad as the scary 3 am episode). I didn?t take anything else for it by mouth, but I put some triamcinolone acetonide over the area of the shot and that stopped the itching enough to sleep. Arm soreness continues but is minor.
Less than 24 hours after receiving flu vaccine in R deltoid, had onset of swelling and pain in R axilla. On exam, patient's R axilla was tender and diffusely swollen encompassing an area of approx. 10 cm diameter, without palpable lymphadenopathy. No erythema at injection site nor in axilla. Recommended symptomatic treatment with ibuprofen. Patient reported same reaction after flu shot a year ago: onset of pain and swelling in R axilla after flu shot in R deltoid less than 24 hours after injection. Was seen at urgent care and treated with doxycycline. Swelling resolved after a few days.
Initial report received on 28 September 2009 from a non health care professional. An eleven month old female patient developed cough, fever, excessive crying, irritable, and a runny nose seven and a half hours after receiving FLUZONE intramuscularly (lot number not reported) on 26 September 2009 at 10:30 AM. The patient has not recovered. Follow-up information was received from the consumer on 13 October 2009. The patient received the injection in the thigh, and other medications included TYLENOL. She had not received any previous doses of FLUZONE, and was not ill at the time of vaccination. List of Documents held by Sender: none.
This spontaneous report as received from a registered nurse refers to a 16 year old male patient. Information regarding relevant medical history and concurrent condition were not reported. On 19-FEB-2016 the patient was vaccinated with an adult dose of VAQTA (lot # L017757, expiration date 08-APR-2018, 50/1.0 U/ml, 1.0 ml, intramuscular) (accidental overdose). Information regarding concomitant medications was not reported. No adverse effects were reported. Additional information has been requested.
Patient had peri-orbital swelling, facial hives, facial swelling and red spots on trunk, progressing over the course of 15 minutes.  He was seen in the ER and symptoms improved with Benadryl, Decadron and Tagamet. No respiratory distress.
4 month old infant received Kinrix; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 provided as follows: It was reported that the 4 month old patient received Kinrix, which led to inappropriate age at vaccine administration. No adverse events reported. The reporter did not agree to follow up.
Narrative:  Patient received Moderna vaccine dose #1 on 6/8/2021 and dose #2 on 7/13/2021. He presented to the ED on 12/4/2021 with chief complaint of generalized weakness. He had a low grade fever of 99.6. He was admitted to the hospital and started on remdesivir and dexamethasone.
24 hours later, red and hard lump at injection site (swelling) peaked at 3rd day, not "pain" more itching and redness and warm to touch 6" x 3" rectangle red area - all in right arm - ADACEL injection site.
10 cm, redness, swelling, warm to touch told patient to take Benadryl Elixir and use cool compresses.
Swollen and painful left infraclavicular lymph node 2 days after 2nd COVID vaccine
This case was reported by a consumer and described the occurrence of pain in a 65-year-old female subject who was vaccinated with influenza virus vaccine (manufacturer unspecified) for prophylaxis. A physician or other health care professional has not verified this report. The subject's medical history allergy to ampicillin, allergy to Keflex, allergy to Lorabid, allergy to Percodan, bee sting allergy, bullous lung disease, Codeine allergy, lung surgery and tetracycline allergy. Concurrent medications included Esomeprazole (Nexium) and Combivent. The subject reported that she had received influenza virus vaccine in previous years with no subsequent adverse events. On 25 September 2006 at 12:30 p.m., the subject received a dose of Influenza virus vaccine in the right arm. "That same evening", on 25 September 2006, at an unspecified time after vaccination with Influenza virus vaccine, the subject experienced "arm pain which radiated to the neck". The subject was seen at the physician's office. The outcome of the event was not reported.
Patient noticed significant shoulder pain upon waking 8/19/15. Pain has not disappeared and resulted in a dr. visit 8/31/15.
About 11 hours after I took the shot, I start feeling very hot and my whole body started shivering very badly from toe to head, I had extremely bad headache,  felt nauseous and my whole body was hurting. I took 2 Tylenol 650mg but it did not do anything. My temperature was high (reached 101). The whole thing lasted  few hours non stop. After that, I have light to moderate headaches almost every day (till this day)
Information has been received from a nurse concerning a 12 year old female with no pertinent medical history or drug reactions/allergies who on 07-MAR-2011 was vaccinated with the first 0.5ml dose of GARDASIL (lot #666929/0331Z, expiration date in November 2012) intramuscularly in the left arm. Concomitant therapy included MENVEO same site with GARDASIL and HAVRIX in right arm. On 07-MAR-2011, the patient experienced injection site reaction. Injection site reaction was described as a tender, 10mm raised, red area at the injection site on the left arm. On 09-MAR-2011, the patient came to the office complaining of the site reaction. The patient was treated with MOTRIN, ice and BENADRYL. No lab diagnostics studies were performed. Reporter could not determine at the time of the call which vaccine caused the injection site reaction. The current status of the patient was not known at the time of the call. Follow-up information has been received from the registered nurse concerning the 12 year old female with no known drug allergies who on 07-MAR-201 was vaccinated intramuscularly in left deltoid with the first dose of GARDASIL (lot#666929/0331Z). Secondary suspect vaccination administered on the same date included a second dose of VARIVAX (lot # 667237/1357Z) (vaccinated subcutaneously in left deltoid as well). Subsequently the patient experienced local site redness swelling (10 cm in diameter, local treatment (ice packs) BENADRYL etc.). The patient did not seek medical attention. The patient recovered on an unspecified date. Additional information is not expected.
Patient has "moderna arm" - red patch on arm around the injection site that appeared ~8 ish days after vaccine
I had normal side effects like the flu twelve hours after. The following day I had really bad anxiety and insomnia and my period came early. I could not sleep and I was very anxious. I was very scared and jumpy and restless for no reason. The news of the vaccine safety issues had not been released yet. I went to the ER and I was given anxiety medication. It lasted for a week and I could not sleep at all. I got my period three days after the vaccine and that was three weeks early and it was lighter than normal.. I normally have regular periods. My anxiety has been better and I am sleeping normally.
Pt. stated she started feeling tingling in her fingers 5 min. after getting vaccinated.  The tingling on her fingers went away but she started feeling tingling in her knees.  Vital signs were taken.  O2 sat 100%, BP 134/63, HR 86.  Patient stated she was nervous when vaccinated, but the tingling was new.  At 3:53 pm patient stated the tingling is going away on its own.  At 4:01 pm she stated she was feeling ok and is ready to go home.
August 27, 2022 was the onset of symptoms. I woke up and felt lethargic. I was tired and a good night's sleep didn't rectify anything. I didn't have a fever but just a little bit of a cough. We were traveling and the first morning I just woke up feeling tired. We called the health authorities and told them we were positive for COVID-19. They told us to mask up and carry on. The only medication I took was MAX cold and flu for the congestion and cough. I wasn't running any temperatures. It lasted about a week. We returned home on September 2, and I tested negative 10 days after the onset. Roughly a week after I tested negative, I started having episodes of lightheadedness. I was running up the stairs and all of a sudden, I was winded and lightheaded. On September 19, I went to see my internist for an annual exam and by the time I saw her, I was fine and had no COVID-19. She did an ECG and she found that I had an irregular heartbeat. We phoned and got an appointment on November 2, 2022 with my cardiologist. By the time I saw him on the 2nd, the irregular beat had cleared itself. My wife would also listen to my heartbeat, and you could hear the irregularity. By the time I went to physically see my cardiologist, it was fine. Interestingly, medical centers had studies regarding that this could happen after the COVID-19 infection, but my cardiologist did not think it was in relation. On November 2nd, I also did receive my 3rd Moderna bivalent booster (5th dose). I'm feeling great and fine now. The symptoms of the lightheadedness and irregular heartbeat lasted about 2 weeks. The irregular beat stayed for those 2 weeks and the lightheadedness came and went.