chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna Covid-19 vaccine that had undergone 1 temperature excursion was administered to patient on 27-May-2022; Moderna Covid-19 vaccine that had undergone 1 temperature excursion was administered to patient on 27-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine that had undergone 1 temperature excursion was administered to patient on 27-May-2022) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that had undergone 1 temperature excursion was administered to patient on 27-May-2022) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060A22A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that had undergone 1 temperature excursion was administered to patient on 27-May-2022). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine that had undergone 1 temperature excursion was administered to patient on 27-May-2022). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine that had undergone 1 temperature excursion was administered to patient on 27-May-2022) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that had undergone 1 temperature excursion was administered to patient on 27-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was reported that patient received first booster dose and second booster dose. It was reported that two warm temperature excursions occurred with two different batches of the same lot number of the Moderna COVID-19 Vaccine. The two different batches of vaccine were stored in the facilities freezer. The first set of Moderna COVID-19 vaccine reached 7.9 degrees Fahrenheit in a freezer for 10 minutes. This excursion occurred on 23-May-2022. The second lot number of Moderna COVID-19 vaccine that underwent an excursion on 08-Jul-2022 10 vials of vaccine reached 6.24 degrees Fahrenheit for 39 minutes. No side effects or Adverse Reactions were known from the Primary Series.   This case was linked to MOD-2022-608601 (Patient Link).
Muscle aches all over started about a day after vaccination. Those aches went away in maybe 6 hours or so.
None known - nurse advised pt. to be aware of rash, joint pain, fever, etc.  Contact MD if any s/s are worrisome.
04/01/23 presents to ED for "breathing problem". PMHx of "hypertension, hyperlipidemia, CHF, BPH"
9/3/13 patient received vaccinations. She was seen in the clinic on 9/5/13 with fever and vomiting. Patient was then taken to urgent care on 9/7/13 due to fever and rash. TYLENOL, MOTRIN, BENADRYL given and relieved symptoms.
Fever of 103°F, chills, body aches, nausea, fatigue and headache for 12 hours starting 6 hours after receiving the vaccine
Pt has an all over body rash, not just in the injection site area. Doesn't know if this is causing or not.
Patient received Bexsero at dose 1. MENVEO was administered at dose 2, instead of BEXSERO.  Patient did not complain of any adverse reaction/side affects.
Sore arm x1 day at injection site; This is a spontaneous report from a non-contactable healthcare professional. A 31-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 22Jun2021 at 10:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. It was unknown whether the patient was pregnant. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 22Jun2021, the patient experienced sore arm for one day at injection site. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event sore arm for one day at injection site was resolved on 23Jun2021.   No follow-up attempts are needed. No further information is expected.
No adverse events. A flu shot was given to a 4 month old. Parents were informed of incident.
profusely sweating non stop; Unable to walk around; Exhausted; Shivering / Cold; Intense pain all over /  her entire body was hurting / not one part of me wasn't hurting; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 18May2021 12:00 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Factor V Leiden homozygote" (unspecified if ongoing), notes: Factor v Leiden homozygous. The patient took concomitant medications. Vaccination history included: BNT162B2 (DOSE 1, SINGLE  (Lot number: UNKNOWN), Location of injection: Arm Left, Administration time: 18:00), administration date: 27Apr2021, when the patient was 39 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 19May2021 03:00, outcome "recovering", described as "Shivering / Cold"; PAIN (non-serious) with onset 19May2021 03:00, outcome "recovering", described as "Intense pain all over /  her entire body was hurting / not one part of me wasn't hurting"; GAIT INABILITY (non-serious) with onset 20May2021, outcome "recovering", described as "Unable to walk around"; FATIGUE (non-serious) with onset 20May2021, outcome "recovering", described as "Exhausted"; HYPERHIDROSIS (non-serious) with onset 21May2021, outcome "not recovered", described as "profusely sweating non stop". Therapeutic measures were not taken as a result of chills, pain, gait inability, fatigue, hyperhidrosis.  Additional Information: The patient did not have any allergies to medications, food, or other products. Concomitant medication included unspecified anxiety medication since an unknown date and unknown if ongoing. 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 COVID vaccine. The patient reported that on 19May2021 at 03:00, the night she took the second vaccine, she woke up shivering in intense pain all over from how cold she was and her entire body was hurting. She stated that she was unable to walk around on 20May2021, the following day and not one part of her was not hurting. She clarified that on 20May2021, the next day her symptoms were improved but she was exhausted and its currently 21May2021, day three now and was profusely sweating non-stop. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I am having allergic reactions; I am itchy like allergic reaction in different parts of my body; I am having allergic reactions; I am itchy like allergic reaction in different parts of my body; I have a lump under my left armpit. I have a lump and it hurts, it is swelled up; I have a lump under my left armpit. I have a lump and it hurts, it is swelled up; My breast hurts as soon I received the dosage around my breast, around my areola it was burning, it burned a lot; My breast hurts as soon I received the dosage around my breast, around my areola it was burning, it burned a lot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A male patient received bnt162b2 (BNT162B2) (Lot number: FH8028) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "I am having allergic reactions; I am itchy like allergic reaction in different parts of my body"; INJECTION SITE MASS (non-serious), SWELLING (non-serious), outcome "unknown" and all described as "I have a lump under my left armpit. I have a lump and it hurts, it is swelled up"; BREAST PAIN (non-serious), BURNING SENSATION (non-serious), outcome "unknown" and all described as "My breast hurts as soon I received the dosage around my breast, around my areola it was burning, it burned a lot".  No follow-up attempts are possible. No further information is expected.
The pt experienced malaise, then the pt suddenly stiffened and had an odd look in the face and was unresponsive. The pt's face became pale and he experienced perioral cyanosis. 12-13 minutes later the pt acted normally and was taken to the ER. The pt had a fever of 104.
This report describes the occurrence of autism in a 28 month old male who was vaccinated with hep B vaccine recombinant (Engerix B) for prophylaxis. This report was received from manufacturer (HQ5640406DEC2002), who received it from the subject's mother. This report has not been verified by a physician or other healthcare professional. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject reportedly received injections of Engerix B on 5/4/00, 6/7/00 and 2/28/01; lot numbers were not provided. The notifications from manufacturer indicated that the subject's mother reported to manufacturer that the subject received a diagnosis of autism in September 2000, approximately 19 months following receipt of the third injection of Engerix B. Treatment and outcome of the event were not known. The autism in this report is considered medically serious (OMIC).
positive covid antigen saliva rapid test; positive covid antigen saliva rapid test; This is a spontaneous report received from a non-contactable reporter (nurse). An adult female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 25Mar2021 (Lot number: EL3247) as dose 2, single and administration date 04Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "exposure to unvaccinated children 10Nov2021 who likely got it at school", start date: 10Nov2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Nov2021, outcome "unknown" and all described as "positive covid antigen saliva rapid test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Nov2021) positive. Clinical course: positive covid antigen saliva rapid test on 11Nov2021 after exposure to unvaccinated children 10Nov2021 who likely got it at school.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 in this patient cannot be completely excluded.
Patient was administered incorrect dosage of Pfizer (0.1).  Vaccinator notified site leader in regards to the above.  Site leader contacted patient and advise tp return to facility to receive the remaining dosage of 0.2.  0.2 was administered and patient was fully vaccinated with the correct dosage of 0.3.
I was fine when getting the injection and my ½ hour wait. I was fine during dinner and after dinner and until about 9 hours after the injection when my arm felt exceedingly sore. I had been watching a free Amazon Prime cute movie while knitting a blanket for my grandson. When the movie was over and I was clearing my knitting, I noticed my super sore arm. I got up to check my face in the mirror to be sure that I was not having a reaction. But I did have a reaction with a rash on my chest and face 9 hours after the injection. My arm really hurt for three days but is fine now.  When I saw my red face and chest, I took a Zyrtex D and a Benadryl.  It did not seem to help the redness to go away. When I felt some tightening of my throat and started to feel that I might be starting to lose some clarity of thought, I quickly watched a minute video on how to use my new kind of generic epipen and jabbed myself in the leg and called 911.    I felt much better after the epipen in terms of my thinking and throat.  Basically, the medics that came to the house and said that I had taken what they would give me at the hospital and it was up to me if I wanted to go to the emergency room or not; they would take me but I would need a ride home. With the pandemic and 48 new cases, I decided to stay home and I went to bed; the rash on my face was gone in the morning. The next days I just felt muscle soreness all through my body (day 2) and felt tired (next two days) but had no fever at any time.  I am fine today. I appear to have two very small areas on my chest that probably related to the reaction.
Approximately 48 hours after receiving Moderna bivalent booster from her workplace employee health provider, patient developed red itchy rash to bilateral upper legs, lower abdomen, lower back, posterior upper neck.   No shortness of breath, chest tightness, facial swelling, or signs of anaphylaxis.  Presents to Clinic 11/25/22  (8 days post vaccination) with persistent rash and itching.
04/25-28/2021: blockage of right ear, audio distortion with severe headache 04/28-05/01/2021: tinnitus started on right ear, headace continues, blockage of right ear goes away 05/02-03/2021: blockage comes back again, ringing gets worse, audio distortion continues, headace, dizziness 05/04/2021: blockage dissapating, right ear ringing becomes multiple sounds, ringing starts in left ear as well 05/05/2021: ringing volume is increasing, mixed sounds 05/06/2021: blockage comes back, ringing in both ears continues with mixed sounds, went to PCP and checked ear, no infection or wax 05/07/2021: went to ENT doctor, did audiogram, no hearing loss confirmed, possibilty of inflamation symptoms due to vaccine by doctor, similar symptoms (minus tinnitus) were felt a year prior months after infected with covid, no prescription given  Since April 25th, significant decreased function due to ear issue, unable to concentrate, tired, difficulty sleeping
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA298495, 2018SA298512, 2018SA297575, 2018SA298701, 2018SA298573, 2018SA298593, 2018SA298603, 2018SA298611, 2018SA298622, 2018SA298631, 2018SA298644, 2018SA298649, 2018SA298692 and 2018SA298695 (same reporter). This case involves a patient of an unknown demographics who received 5 ml dose of vaccine FLUZONE HIGH DOSE lot U1995AB, expiry date:20-Jun-2019 via intramuscular route (site of administration not reported) on an unknown date (between 01Oct2018 to 08Oct2018). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccine was administered. It was actual medication error due to incorrect product storage and overdose (patients were injected with this previously frozen FLUZONE HD). It was reported that patients were injected with previously frozen FLUZONE HD. The caller stated that the staff were unaware that temperature reading from the refrigerator showed that the FLUZONE HD vaccines were frozen at some point in time. It was unknown whether patient experienced any adverse reaction after vaccination. 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. Documents held by sender: none.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 07-FEB-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R019391 with expiration date 05-JUL-2020  (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Patient was in her usual state of health at home on 02 Sep 2019, when she developed fairly sudden onset of severe R shoulder and arm pain.  Evaluated in ED and found to have low-grade fever, swelling and redness extending from right chest area thru right shoulder and arm, and severe R arm pain, limiting any movement.  Admitted to Internal Medicine on 03 Sep 2019.    Initial concern for infxn prompted empiric abx.  Tx resulted in resolution of swelling and redness, and reduction in pain - although 8/10 R shoulder and R wrist pain persist.  Care team questioned whether Shingrix vaccine (RZV, dose #1, administered IM in R deltoid on 09 Aug 2019) could be related to persistent R arm pain.  Immunization Healthcare team consulted.
Patients arm got severly swollen red hot to touch huge lump. It's sore it hurts he can't lay on it. It's the size of a baseball swollen. Just giving him Tylenol and ibuprofen to help with swelling And pain.
Patient had pain in site of injection, it went away, but she said it came back again after couple of weeks.
CANNOT SIT AND LAY DOWN SOMETIMES; LINGERING PAIN; FELT HOT; CHILLS; SHOULDER TO SHOULDER PAIN ALL DAY ALL NIGHT; MIDDLE BACK PAIN; INABILITY TO CATCH BREATH; FEVER; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included radiculitis/radiculopathy, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: 11-MAR-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, treatment medications included: oxycodone hydrochloride/paracetamol. On 11-MAR-2021, the subject experienced fever. On 12-MAR-2021, the subject experienced middle back pain. On 12-MAR-2021, the subject experienced inability to catch breath. On 12-MAR-2021, the subject experienced shoulder to shoulder pain all day all night. On 13-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced felt hot. On an unspecified date, the subject experienced cannot sit and lay down sometimes, and lingering pain. Laboratory data (dates unspecified) included: CT scan (NR: not provided) negative and no abnormalities. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 13-MAR-2021, and had not recovered from middle back pain, inability to catch breath, felt hot, shoulder to shoulder pain all day all night, cannot sit and lay down sometimes, and lingering pain. This report was non-serious.
developed symptoms and was tested positive for covid-19 infection; developed symptoms and was tested positive for covid-19 infection; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient developed symptoms and was tested positive for covid-19 infection on 25Jan2021 with outcome of unknown. He was receiving monoclonal antibodies today (27Jan2021). The patient underwent lab tests included covid-19 virus test: positive on 25Jan2021.    Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.