chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions. Twenty six patients received the vaccine in question.) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not reported. Storage condition at the time of the excursion is refrigerated storage. Maximum Temperature reached is 49 degrees Fahrenheit and Minimum Temperature reached is 37.7 degrees Fahrenheit. Vial moved from freezer to refrigerator on 3-MAR-2022. The Nurse reports no adverse reactions or side effects to the Moderna COVID-19 vaccine. Proposed desired use by date was reported to be on 16-Mar-2022. The temperature excursions occurred on 4-Mar-2022, 5-Mar-2022, 7-Mar-2022, 8-Mar-2022, 9-Mar-2022 and 10-Mar-2022. Treatment information was not reported.
Within 45-60 seconds of receiving the vaccine, I experienced acute-onset of tachycardia of 130-140s BPM. For context, my resting heart rate is 65-80. At first, I assumed it was anxiety, however, I had no preconceived notions or negative thoughts regarding the vaccine. I took slow, deep breaths and performed a vagal maneuver which did not lower my heart rate. I took two Claritin pills, thinking this was a mild allergic reaction. 30 seconds later, I tried to vagal again and successfully slowed down my HR to approximately 100-105 BPM. The tachycardia resolved after 10-15 minutes.
Fever to 102.5 x 72 hours, small localized erythema 2 areas x 1-2 cm each, papules, blisters x 8, upper outer quadrant right thigh.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt vaccinated with Recombivax HB developed progressive weakness in rt leg dx as transverse myelitis. Possibility of lumbosacral plexus inflammation was also considered.  A cerebrospinal fluid tap was positive for 300WBC/ML.
Shivering even when it was really warm Sensitive skin to touch Sweating profusely  I went from freezing to overheating out of nowhere Puking  Dizziness  Pounding headache in back of head for about 10 hours Body aches muscular Felt like my hip bones up my spine and neck were hurting  I finally was able to take exedrin and after an hour I was able to relax a little. Enough to fall asleep for a couple hours.   2 hours after I got the shot I started feeling effects. I didn?t sleep until 0400 in the morning because I was in so much pain. Today I have a headache and my body is sore but I feel a lot better.  If I didn?t live so far away from my friends or coworkers I would have gone to the hospital. I was too weak and sick to use my phone.
1. Baby stopped making eye contact with people 2. Stopped smiling 3. Erections ceased 4.  Stopped reacting to things such as toys, peek-a-boo, tv 5. Didn't urinate for over 12 hours (this happened 2 times in in the 2 days following the vaccination)
Information has been received from a physician concerning a 10 year old male who on 06-JUN-2000 was vaccinated with his first dose of MMR II. Diagnose on 20-NOV-2009 revealed the patient had parotitis R and the patient was afebrile. On 08-DEC-2009 the patient experienced mumps. Follow-up information was received which reported that on 06-DEC-2009 the patient experienced mumps. Diagnose on 06-DEC-2009 revealed the patient had parotitis on both sides. Additional information has been requested.
vertigo - started within 15 min of first injection.  resolved 2 days before second injection on 4/21/21.  recurred with second injection and has not completely resolved.
This spontaneous report as received from a healthcare worker, practice manager refers to a unknown patients of unknown age and gender. On an unknown date the patients were vaccinated with VAQTA (dose and route not provided). The health care worker reported, the storage compartments that contained VAQTA were not monitored at all from 03-MAY-2014 until the report time. Doses of the vaccine that were exposed to unknown temperatures were administered to unspecified patients. The practice manager will provide the names of the patients who received doses of the un-monitored vaccines in during the period of time from 03-MAY-2014 until the present. The reporter stated that her practice has not been informed of any adverse experiences No additional information was provided. This is one of several reports form the same source. Additional information has been requested.
MD reported that pt did not seroconvert following vax w/MMR on 29OCT90; mom of the pt wasnotified by school pt was attending that the lot of MMR vax was weak; no further details were provided;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with the ZOSTAVAX vaccine at a medical center as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Additional information has been requested.
At roughly 6 days after vaccination my body developed Hives head to toe. Roughly 18 or so hours after initial hive development I sought treatment for a anaphylactic reaction in my throat and face area. I received a steroid and a Pepcid to calm it down, and was given an epi pen and sent on my way. The following now two plus weeks since then I've had episodes of dizziness, shortness of breath and headaches that seem to be constant. There has been almost no relief from these symptoms, however the rash has completely resided. I've taken an Aspirin in the mornings to deal with the headaches but strenuous activity seems to bring these on much more prominently.
6 year old patient was administered the dosage for a 4 year old.  No adverse side effects noted.  Mom plans to return to office to repeat vaccine at proper dosage
SWOLLEN FACE; DIFFICULTIES BREATHING; WEIGHT IN HER CHEST; FLUSHING; HEART PALPITATIONS; CHILLS; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced swollen face. On 26-MAR-2021, the subject experienced difficulties breathing. On 26-MAR-2021, the subject experienced weight in her chest. On 26-MAR-2021, the subject experienced flushing. On 26-MAR-2021, the subject experienced heart palpitations. On 26-MAR-2021, the subject experienced chills. On 26-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, swollen face, difficulties breathing, weight in her chest, flushing, nausea and heart palpitations was not reported. This report was non-serious.
Acute Appendicitis with rapid onset (within 12 hours of symptoms) without prior symptoms. Requiring Appendectomy. According to the surgeon the severity of the inflammation was such that this could not have developed within 12 hours prior to the appendectomy.
a patient was administered an expired dose of ActHib, no AE; Initial information was received on 06-Oct-2020 regarding an unsolicited valid non-serious case from the nurse via phone.  This case involves a 15 month old female patient who was vaccinated with a 0.5 mL dose of an expired HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ079AAA and expiration date 02-Oct-2020) via an unknown route in the right thigh on 06-Oct-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient was concomitantly vaccinated with PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVENAR) and INFLUENZA VACCINE [FLU] for prophylactic vaccination on 06-Oct-2020.  This was case of an actual medication error case due to expired vaccine used (latency was same day).  At the time of reporting, no adverse event was reported to the patient.  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 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.
I started feeling ill 2 days after I got the vaccine.  Today, the third day after the vaccine, I still wasn't feeling well and was running a fever still.  I tested myself for COVID and it was positive.  I looked up online and it said the vaccine wouldn't cause a false positive, so I'm relatively certain I have COVID.  I have not been exposed as far as I know, and it seems really coincidental that I would get COVID immediately following the vaccine.
fever18 hours later, 2 days later severe headache and light sensitivity lasting 24 hours.  Several days later asthma flared up and continues to get worse.  Pre vaccination asthma only triggered after exercising  then entering the cold weather and Hx of asthma triggered with BP medicines known to trigger asthma.  Since the 2nd vaccine asthma is getting progressively worse and having to take rescue inhaler daily.
several bouts of diarrhea after the Pfizer Covid Vaccine (1st One)
Patient started feeling weakness in extremities after his Booster shot. It's been getting worse since then and now he can barely walk. Patient contacted his doctor. No tests were done to this date. Doctor said to call the pharmacy where he got his shot.
01/15/2022 I started to have a little bit of a sore throat. On 01/16/2022 I decided to take a PCR test and tested negative for COVID. I felt like I had cold like symptoms. A runny nose, a headache. My symptoms were not too bad. I did take ibuprofen. I took another rapid test on 01/21/2022 and it was still positive. I went back to work on 01/26/2022. I did another rapid test on 01/27/2022 and it was negative.
Information has been received from a registered nurse concerning a 30 year old male patient who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 647660/0945N, Subsequently 4-5 hours post vaccination, the patient developed warmth, redness and swelling at injection site, the patient was treated with an unknown antibiotic. The patient was reportedly recovering. It was also reported that another patient had a similar reaction (WAES0408USA01563). Additional information has been requested.
patient with h/o fear of needles during observation period starting thinking about vaccine, arm pain developed dizziness, became lethargic noted to have hypotension with systolic blood pressure in 80's, HR in 30's, 911 called
Site: Redness at Injection Site-Medium, Systemic: warm to the touch at injection site-Medium
no adverse events; expired vaccine; This spontaneous report was received from a nurse referring to a 3 years old patient of unknown gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.  On 26-MAR-2021, the patient was vaccinated with a single dose of expired vaccine haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # R013573, expiration date 22-MAR-2021, dose and route of administration were unknown) for prophylaxis. No prior temperature excursions reported on the product. No additional adverse events were reported as a result of receiving the expired vaccine.
congestion in her head; tender and painful at the injection site; sore throat; bad cough; achy; Initial information received on 29-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves a 52 years old female patient who experienced sore throat (oropharyngeal pain), bad cough (cough), was achy (pain), had congestion in her head (head discomfort) and was tender and painful at the injection site (vaccination site pain), while she received vaccine influenza quadrival a-b vaccine [Fluzone Quadrivalent].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included sodium (NA).  On 20-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (with unknown strength, formulation, dose, frequency, lot number and expiration date) via unknown route in the right arm for prophylaxis vaccination.   On 22-Oct-2020, 2 days after administration of suspect vaccine, sore throat (oropharyngeal pain), bad cough (cough), achy (pain) and stated intense for 3-4 days.  On an unknown date, (latency unknown) after administration of suspect vaccine, had congestion in her head (head discomfort) but it was less troublesome than the cough and was tender and painful at the injection site (vaccination site pain).   She has had flu vaccines before but did not knew the brand and had not done well with them and stated for many years she did not get a flu vaccine due to this but had to take care of her dad so did this year.   No laboratory data was provided.   Patient received inhalers and had 2 courses of 10 days steroids, codeine type syrup for cough and it was not reported if the patient received a corrective treatment for other events.   At the time of report, the outcome was not resolved for cough and head discomfort while unknown for other events.     There would be no information available on the batch number for this case.
Inadvertent administration of Vaxelis and Rotateq after temperature excursion; This non-serious spontaneous safety report, with reference number 02430542, was received by a partner on 19-JUL-2023 and forwarded on 20-JUL-2023, from a non-HCP.  The causal relationship between Vaxelis and the reported event "Inadvertent administration of Vaxelis and Rotateq after temperature excursions" was assessed as not applicable due to the nature of the event.  Further information is expected.  Significant Follow-up information was received by the partner on 03-APR-2023 and forwarded on the same day, from a physician. This case is maintained as non-serious.  The causal relationship between VAXELIS and the reported event of "Inadvertent administration of Vaxelis and Rotateq after temperature excursion" was assessed as not applicable due to the nature of the event.  No further information is expected.
Awakened with moderately severe neck pain and stiffness (unexplainable by any recent physical activity), and frontal headache or/and  sinusitis but without yellow or green discharge. This was followed by onset around 12:00 noon of myalgia, arthralgia, and fairly severe fatigue, all of which worsened over course of the afternoon. These Sx were partially relieved by acetaminophen. Afebrile throughout. I should note that 45 min. after the vaccination I had a brief episode of asthmatic Sx/shortness of breath, and tightness in throat, relieved by taking 50 mg of diphenhydramine PO, however these may have been unrelated to vaccine and due to pre-existing asthma and allergies. By approximately 9:00 PM yesterday I also had soreness and slight induration and heat around injection site, all resolved by this morning and far milder than a previous local reaction last month to Pneumovax.
Head ache, Sore muscles, dizzyness, lack of color, fevor, nausa, stomach pain.
The Pfizer vaccine was mixed incorrectly (too much diluent used), so the patient received an invalid dose.
ain in arm that has lasted a year; This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   The reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine and experienced Pain in arm which lasted for a year. The reporter consented to follow up.
Patient had a headache for 6-7 days, extreme tiredness, then extreme left upper jaw pain that followed after headache for 7 days pt went to dentist for an exam everything dental was fine. Pt feel it was related to the shot and nothing else.
syncope, two minutes after Gardisil vaccine.Our office has given about 50 vaccines, and two people have had syncope after the injection. I don't think that is good.
lips starting to swell like a balloon (angioedema); headache; chills; This is a spontaneous report from a contactable other hcp (patient).   A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, at age of 39 years old, administered in Arm Left on 10Apr2021 13:30 (Lot Number: ER8729) at single dose for covid-19 immunization.  Patient is not pregnant at the time of vaccination. The patient medical history was not reported. Known allergies was None.  The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20Mar2021 (age of 39 years old)(Lot Number: EN6208) at single dose for covid-19 immunization. The patient had 2nd vaccine on 10Apr2021 at 01:30 PM, woke up 11Apr2021 11:00 AM with headache and chills, then around 11 noticed lips starting to swell like a balloon (angioedema). No hives. Events resulted in Doctor or other healthcare professional office/clinic visit. Outcome for events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the angioedema.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sore arm; Swelling at shot site; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney issues" (unspecified if ongoing); "Cardiac issues" (unspecified if ongoing); "Known Allergies" (unspecified if ongoing), notes: Unspecified. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm"; VACCINATION SITE SWELLING (non-serious), outcome "recovered", described as "Swelling at shot site".  Additional Information: The patient received medications (unspecified) within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced sore arm and swelling at shot site (vaccination site swelling). The clinical outcome of events sore arm and swelling at shot site was recovered on an unknown date with duration of 2 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021401349 Same patient and drug, different dose and events
This spontaneous report as received from a nurse refers to a 8 months 8 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) liquid PEDVAXHIB (injection, lot # K016965, exp date: 20-JUL-201)(dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.