chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient received some of the vaccine, no AE; the syringe detached like it was defected, no AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist  This case involves a 3 years old patient who received some of the dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (batch number, expiry dates were not reported) via unknown route in unknown site of administration, on an unknown date due to the syringe detached, like it was defected.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to vaccine underdose. It was also a case of syringe issue. The issue with the syringe occurred while she was administering the vaccine  At the time of reporting the patient had no adverse event.  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.  Information on the batch number was requested.  List of documents held by sender: none.
Narrative: Patient passed away due to COVID-19. He had received the COVID-19 vaccine.
Redness around injection extending 4-5 inch away. Blotches of redness. Day after - chills/nausea. Area warm to touch.
I think that my blood pressure went really high to 180 up to 200. I went to the dentist to have a tooth extracted and they were unable to complete it because of the high blood pressure. I could feel my heart racing and beating. It would wake me up in the morning but I was not feeling right. I reached out to my doctor via email and provided the ranges that I was having as well as the issue I was having with the extraction. The doctor gave me propranolol. I went back to get my tooth extraction and my blood pressure was still high. The increased the medication which still did not get me into normal range so the doctor added an additional Losartan. The doctor had me come in and did a check up on my heart which she indicated was ok. My provider is having me come back in to complete an EKG. On February 03, my BP was 150/90 so I was advised to return in 3 months and remain on the medications and return in May. I am back in an acceptable range to have the tooth extracted so I had that done a week ago.
After each booster I have experienced dizziness/vertigo when I turn my left ear down (so, lying on my left side, leaning left out of a chair to pick something up, performing a yoga posture that leans left).  I've also have a pretty big lymph node response on that side each time.  That happened this time too, but then after a couple weeks I developed a monster of a cough and then what I would describe as the worst cold I've had as an adult.  No positive covid tests (I home tested every day for a week), but fever, cough that would not stop and did keep me awake pretty much constantly, complete loss of voice down to the tiniest whisper, total exhaustion.  We tried various cough suppressants and such, as well as oral steroids to see if it was my asthmatic lungs overreacting to things, but I was really uncomfortable and exhausted for fully 3 weeks, but then after that: my blood pressure went up and isn't interested in coming down.  This could just be an expected age-and-genetics outcome, but the timing is kind of hinky.  I'm also short of breath pretty constantly even though we added more inhaled stuff (advair) and have some some nebulizering with albuterol etc, which helps for a couple of days then reverts.  We did a chest x-ray to verify I didn't have pneumonia, although I don't know whether they carefully looked at heart things.  I'm going in for more blood pressure checks (where I expect the small dose of something that should be reducing the pressure to be increased because I don't think it's coming down based on pharmacy automated machine checks) and a stress test.  We did an EKG which looked okay, so that's promising.  I have no proof any of this has anything to do with the bivalent covid vaccine, but I also do note that there's some increase in stuff like myocarditis and so here I am telling this story.
This is my first pregnancy and I got pregnant on January 20th of 2021 and I miscarried on April 9th 2021 after my first dose of the Covid vaccine
18 hours after vaccine, severe muscle/bone pain on entire left side of body.  Swelling of left armpit/lymph node- still present 8/29/21 at 7:00 pm.
Pain and swelling and redness to (R) deltoid. Ice, ZYRTEC.
The person giving the vaccine did not look at the date & time on the vial before giving it on 02Nov2021 at around 9a.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The person giving the vaccine did not look at the date & time on the vial before giving it on 02Nov2021 at around 9a.) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The person giving the vaccine did not look at the date & time on the vial before giving it on 02Nov2021 at around 9a.). On 02-Nov-2021, EXPIRED PRODUCT ADMINISTERED (The person giving the vaccine did not look at the date & time on the vial before giving it on 02Nov2021 at around 9a.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.  On 01-Nov-2021, the vial or Moderna COVID-19 vaccine was opened at around 11a.  The vaccine administrator did not check time and date on vial, before administering a dose to the patient on 02-Nov-2021 at around 9a.
After receiving 1st vaccine, I could not move my left arm or lie on that arm without crying in pain. The pain started next day at 3:00 am.  Even after second vaccine still not able to lift my arm up or lie on arm without crying in pain.   I am still having pain and discomfort to left arm.  The pain now radiates to under my arm.  It is now June 9, 2021.  I also still cannot lie on left arm.  Chills and fever only lasted one day with both vaccines but the pain and discomfort to left arm is non stop and  Interfering with work duties
Parent phoned clinic 45 min after vaccines administered stated child vomited on the way home. Child had episode of emesis day before too according to mother. No other signs or symptoms reported at that time.
flu symptoms for a coupe of days after they got the booster dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu symptoms for a coupe of days after they got the booster dose of the Moderna Covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced INFLUENZA (flu symptoms for a coupe of days after they got the booster dose of the Moderna Covid-19 vaccine). In November 2021, INFLUENZA (flu symptoms for a coupe of days after they got the booster dose of the Moderna Covid-19 vaccine) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.; Sender's Comments: Non-serious case.
Nasopharyngitis, Wheezing, Medication error. This case was reported by a pharmacist and described the occurrence of an upper respiratory tract infection in a patient who received diptheria and tetanus toxoids and acellular pertusis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix). On an unspecified date, the patient received the first dose of Pediarix. Approximately four days later, the patient received the second dose of Pediarix. This is sooner than the recommended schedule of six to eight weeks between the first and second doses. At an unspecified time following the second dose of Pediarix, the patient experienced an upper respirator tract infection, fever, a common cold and wheezing and was examined at a physician's office. The outcome of the events is unknown.
Patient reported in conversation 2 years after his vaccination that he day he received his Zostavax, he thought he was having a stroke (had all symptoms). He called a doctor and the Dr. told him to come in for an MRI. Not having a stroke but said it was an ocular migraine and they could only trace it back to the vaccine he had earlier that day. Patient diagnosed with ocular migraine after vaccine administered.
RTO 9/21/19 10:34 am ,daughter states checked Pt at night he was C/O chills ,lips were swollen she gave Pt benadryl 50mg  states in the morning swelling better /
13 1/2 x 9 cm erythema (L) upper arm superior induration.
PALE FOR ABOUT A DAY AND HALF; COLD SWEAT; CHILLS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced pale for about a day and half, cold sweat, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pale for about a day and half, cold sweat, and chills. This report was non-serious. This case, from the same reporter is linked to 20210662161.
Bell's palsy left--pain in left trigeminal distribution, facial droop, seen in ER by neurology, diagnosed with Bell's palsy. Treated with prednisone and VALTREX. Facial droop has not yet resolved.
TOOK THREE DOSES THAT WERE NEVER REFRIGERATED; This case (PVX2019-2191) was received form a nurse on 28-Aug-2019. It described a male consumer, who "took three doses that were never refrigerated" (PT: Product storage error), while being on Vivotif (lot number: 3003282) for an unknown indication.  Case report: The consumer took first three doses of Vivotif that were never refrigerated. The doses were taken on 24-Aug-2019, 26-Aug-2019, and 28-Aug-2019.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took three doses that were never refrigerated" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three doses that were never refrigerated" was considered as not applicable.
swelling on face; joint paint; Feels lethargic; Hasn't been able to exercise; has not received 2nd dose; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site), SWELLING FACE (swelling on face), ARTHRALGIA (joint paint), LETHARGY (Feels lethargic) and ASTHENIA (Hasn't been able to exercise) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). On 28-Feb-2021, the patient experienced SWELLING FACE (swelling on face), ARTHRALGIA (joint paint), LETHARGY (Feels lethargic), ASTHENIA (Hasn't been able to exercise) and COVID-19 IMMUNISATION (has not received 2nd dose). At the time of the report, VACCINATION SITE PAIN (pain at injection site), SWELLING FACE (swelling on face), ARTHRALGIA (joint paint), LETHARGY (Feels lethargic), ASTHENIA (Hasn't been able to exercise) and COVID-19 IMMUNISATION (has not received 2nd dose) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant Medication was available. No Treatments Medication was available.
Feeling tired; This is a spontaneous report received from non-contactable reporter (Consumer). An adult male patient received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: Unknown) intramuscular for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Prev dose lot unknown reason= Not available/provided to reporter at the time of report completion), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, Prev dose lot unknown reason= Not available/provided to reporter at the time of report completion), for Covid-19 Immunization. It was unknown if the patient had covid prior to vaccination. It was unknown if the patient had covid test post vaccination.  The following information was reported: FATIGUE (non-serious) with onset 08Dec2021, outcome "recovering", described as "Feeling tired". It was unknown if therapeutic measures were taken as a result of fatigue.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Moderna was given to a patient who was not of age to receive the Moderna vaccine.  Due to the patient's age, she should have received the Pfizer vaccine.  There were no adverse reactions at the time the patient was given the vaccine or during the monitoring of the patient after she received the vaccine.
unusually enlarged right breast; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 13-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: BREAST ENLARGEMENT (non-serious), outcome "unknown", described as "unusually enlarged right breast".  Clinical course: It was reported that physician ordered ultrasound after enlarged breast was reported to the physician. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Slight itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Slight itching at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (Slight itching at the injection site). At the time of the report, INJECTION SITE PRURITUS (Slight itching at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt vaccinated with Rabies possible clinical rabies. Phone report to Dr. at CDC on 20SEP90.
Loss of hearing in left ear. Started with intense ringing, followed by vertigo and then ultimately loss of hearing
UTICARIA RASH WITH VERY INTENSE ITCHING. RASH IS WIDESPREAD AND HAS TURNED OUT TO BE CHRONIC. BENADRYL DOES NOT WORK. TRIAL AND ERROR HAS LET TO COLD SHOWER FOR IMMEDIATE RELIEF AND TAKING CETIRIZINE HYDROCHLORIDE 10MG EVERY 48-72 HOURS TO KEEP SYMPTOMS AT BAY.
2 days after recieving Td booster and Pneumovax vaccines, the patient had sudden onset of left side hearing loss, immediately preceded by a loud sound in the left ear.  This hearing loss has persisted to the present time.  Patient was evaluated at the clinic on 7/3/03 and referred for Audiogram and ENT appts. Audiogram showed total hearing loss in left ear on 7/16/03.  On 7/24/03 she was seen in ENT clinic, hearing loss described as idiopathic, and patient given a prednisone taper.  She has completed the prednisone taper without any change in her symptoms.  An MRI has been scheduled for 10/2/03, and the patient is going to follow up with ENT 8/15/03.  Although the definitive etiology of the hearing loss is unclear, the patient attributes it to the vaccines that she received 2 days prior to the onset of the hearing loss. Left hearing loss has not improved. Pt has follow up appts with Audiology and ENT at hospital 3/1/04. 10/27/03 MRI at hospital showed no explanantion for hearing loss.
felt sick all over woke up 2AM; rt arm very painful 3 nodules-red, raised, h/a stiff neck, chills, temp 101.5, vomiting;
Ischemic stroke on 3/7/21, and STEMI on 3/23/21.
Pt had a febrile seizure on 6-13-14, duration 15 seconds.
Hives on face, shoulders and neck.  Benadryl for the itching and hives
Weakness, declining health, admitted to hospice 6 days later, followed by death on 4/21/21 (9 days following vaccine).
Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder). At the time of the report, ARTHRALGIA (Sore shoulder) outcome was unknown.            Concomitant product was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-292324.
The patient was administered Kinrix vaccine.  No adverse reactions to the vaccine noted.  The dose is valid per system.
Every once in a while has some discomfort in the arm; arm  hot to the touch, very warm the whole area where got the vaccine; where got the vaccine, also hard; arm  is itching; where got the vaccine, also red; arm  is swelling; sore arm for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for a couple of days), LIMB DISCOMFORT (Every once in a while has some discomfort in the arm), VACCINATION SITE WARMTH (arm  hot to the touch, very warm the whole area where got the vaccine), VACCINATION SITE INDURATION (where got the vaccine, also hard) and VACCINATION SITE PRURITUS (arm  is itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm for a couple of days). On 23-Jan-2021, the patient experienced VACCINATION SITE WARMTH (arm  hot to the touch, very warm the whole area where got the vaccine), VACCINATION SITE INDURATION (where got the vaccine, also hard), VACCINATION SITE PRURITUS (arm  is itching), VACCINATION SITE ERYTHEMA (where got the vaccine, also red) and VACCINATION SITE SWELLING (arm  is swelling). On 26-Jan-2021, the patient experienced LIMB DISCOMFORT (Every once in a while has some discomfort in the arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 16-Jan-2021, PAIN IN EXTREMITY (sore arm for a couple of days) had resolved. At the time of the report, LIMB DISCOMFORT (Every once in a while has some discomfort in the arm), VACCINATION SITE WARMTH (arm  hot to the touch, very warm the whole area where got the vaccine), VACCINATION SITE INDURATION (where got the vaccine, also hard), VACCINATION SITE PRURITUS (arm  is itching), VACCINATION SITE ERYTHEMA (where got the vaccine, also red) and VACCINATION SITE SWELLING (arm  is swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Syncope: Patient became pale and was unable to answer questions roughly 2-3 minutes after receiving the vaccination.  Shortly thereafter, his head rolled back and he slumped in the chair for ~10 seconds before regaining consciousness.  After awaking, he regained his senses rapidly and was able to state his name and the date.  I requested he remain in the area for an additional 30 minutes for his safety.  He agreed.
Case number PHEH2015US000477, is an initial spontaneous report received from a physician on 02 JAN 2015, with a follow up received from physician on 28 JAN 2015. This report refers to a 16 years old female patient. Past medical history and concomitant medication were not reported. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: unknown) intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 02 JAN 2015. The patient did not experience any side effects following this administration error (inappropriate preparation of medication). Follow up received from physician on 28 JAN 2015: updated physician comment.
Itching and whelps on R forearm and both lower leg extremities. Client reports she applied alcohol to sites affected. Itching ceased but whelps remained. All s/s associated lasted for approx. 1-2 days.
Blurred vision, extreme headache, vomiting.  Headache progressively got worse.  Not able to speak sentences.  Disoriented and confused.
Swollen lymph nodes under left arm upon waking this morning. Soreness in armpit area of left arm.