chrisvoncsefalvay/vaers-outcomes huggingface dataset:
menopause for 11 years/About 2 months after her 2nd shot had light bleeding for about 3 weeks; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (Lot Number: EN 8729), dose 2 via an unspecified route of administration, administered in arm left on 10Apr2021 (at the age of 61-years-old) as dose 2, single for COVID-19 immunization. Medical history included asthma, Hashimoto's hypothyroidism, migraine headaches and menopause. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (Lot Number: EN 6207), administered in right arm on 19Mar2021 (at the age of 60-years-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was in menopause for 11 years and have never had vaginal bleeding since. About 2 months after her 2nd shot on 05Jun2021, the patient had light bleeding for about 3 weeks. The patient received no treatment for the event. The patient recovered from the event on unspecified date.
Information has been received from a registered nurse concerning a 17 year old female patient with allergic reaction to cephalosporin and no pertinent medical history who on 16-MAR-2011 was vaccinated IM with the third 0.5 ml dose of GARDASIL (Lot number: 667866/1437Z). There was no concomitant medication. On 16-MAR-2011 the patient experienced pain in her left arm after receiving the third GARDASIL. The nurse reported that the patient could not move her arm up to 90 degrees. The patient did not experience this after the first GARDASIL. The nurse reported that an X-ray was done but it was negative. The patient sought unspecified medical attention. On an unspecified date, the patient had recovered. A lot check has been initiated. This is one of several reports received from same source. Additional information has been requested.
immed p/vax area of 4cm became red & swollen of the CR1 thigh;cold pack applied & observed, DPH given to CRl buttock;pt observed 20min;red area still visible;
Outgoing call to patient's mother to discuss incorrect dose amount of Moderna 23/24 6m-11 given on 10/25/23. Patient's ordered dose was 0.25mL but was given approximately between 0.4-0.5mL. Patient's mother expressed understanding and indicated patient had mild side effects this morning which they treated with a dose of Tylenol and patient was able to attend school. Instructions provided to monitor patient for additional or prolonged side effects and contact clinic with any concerns. Additionally, a message sent to patient's PCP informing them of error.
Arm had redness; Arm warm to touch; Arm knot 4-5 inches; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm had redness), SKIN WARM (Arm warm to touch) and LIMB MASS (Arm knot 4-5 inches) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced ERYTHEMA (Arm had redness), SKIN WARM (Arm warm to touch) and LIMB MASS (Arm knot 4-5 inches). On 21-Jan-2021, SKIN WARM (Arm warm to touch) and LIMB MASS (Arm knot 4-5 inches) had resolved. At the time of the report, ERYTHEMA (Arm had redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: No specific follow-up information recorded.
DONOR REPORTED BY PHONE  TODAY, SEPT. 3, 2019 REGARDING RIGHT ARM PAIN/TENDERNESS FOLLOWING  Tdap SHOT WHICH WAS GIVEN ON AUG. 20, 2019. THE PAIN STARTED ON THE FOLLOWING DAY, AUG. 21, 2019 AFTER THE  SHOT AND IS GETTING WORSE AND UNABLE TO MOVE THE AFFECTED ARM FREELY. NO RESPIRATORY DISTRESS/FEVER. NO MEDICATION TAKEN WAS TAKEN. SHE WAS ADVICED TO SEEK IMMEDIATE MEDICAL CARE & EVALUATION.
some of the Covid-19 vaccine ran down his arm/ Administrating vaccine too quickly, pulled the needle out of my arm, some of the vaccine squirt back out of my arm; I guess partial dose administered; Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19May2021 13:00 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, First Dose: Caller reported that he received his first dose almost 3 weeks ago to the day. Caller reported that he believes that he received his first dose of the Covid-19 vaccine 3 weeks ago yesterday on 27Apr2021. Anatomical Location: Left arm), administration date: 27Apr2021, when the patient was 39 years old, for COVID-19 immunisation, reaction(s): "sore arm".  The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 19May2021 13:00, outcome "unknown", described as "some of the Covid-19 vaccine ran down his arm/ Administrating vaccine too quickly, pulled the needle out of my arm, some of the vaccine squirt back out of my arm; I guess partial dose administered"; PAIN IN EXTREMITY (non-serious) with onset 19May2021 13:00, outcome "unknown", described as "Sore arm".  Additional information: patient reported that the person administering the second dose of the Covid-19 vaccine was either too fast and pulled the plunger out of the syringe too quickly or too fast and pulled the needle out of his arm too quickly. He also reported that some of the Covid-19 vaccine ran down his arm and he doesn't believe that he received a full dose. Patient feels second dose much sharper than the first one. His shoulder hurt to touch almost immediately. The person administrating the vaccine gave it too quickly. They both pressed the plunger on the syringe too quickly and pull the needle out of my arm too quickly, so that when they did pull the needle out of my arm some of the vaccine squirt back out of my arm. Nowhere of knowing how much vaccine I lost or how much I got.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
States began to feel flushed and hot, throat felt tight, symptoms progressivly worsened over 90 min, but then subsided and were gone by 2200.
I experienced a couple of episodes of faintness after the first 10 minutes after the vaccine was administered and then I started to have waves of tachycardia symptoms which lasted for two weeks. I talked to my doctor and was advised to treat the symptoms by hydrating myself and continuing to take my beta blockers.
Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 26-Oct-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 26-Oct-2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 26-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 26-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date of refrigeration was given as 26-Oct-2021.  No treatment  medications were reported.
Pt developed a widespread maculopapular rash with onset 03/20/2001. Pt was seen in ER and thought to be secondary to amoxicillin, but antibiotic changed and rash still spreading. Rash worsening when checked in office on 03/23/2001. Pt also experienced a low grade fever.
I have had a prolonged period and then it started again halfway through the cycle  I have been on Yaz birth control for almost 10 years. My period is always very regular, starting on Tuesday and ending on Friday. It is always also light. This month it started as regular on April 6 (same day as first dose of Pfizer vaccine) but did not end until the following Wednesday, April 14. It was heavier than normal. Then my period started again on April 22 and is still on-going (today is April 27). I am not stressed in any way, not about the vaccine or any other life circumstances, I am not sick, I have not had anything else different in my life other than taking the Covid Pfizer vaccine on April 6. I am not pregnant. Nothing else is weird with my body. I did just get the 2nd Covid Pfizer vaccine shot about 30 minutes ago and felt that the benefits of the vaccine outweigh the inconvenience of this very odd period cycle, but I definitely wanted to report it to help the data and to help other women who may be going through the same thing.  I spoke with my primary care provider who wasn't able to find any data about it in the Pfizer vaccine side effects list, because it wasn't looked at when the initial studies were done. He referred me to an OB/GYN but that appointment isn't for another couple of weeks.
Headache, body aches, nausea, chills, painful right arm, swelling of right arm, red mark on right arm began around 10:00pm on day of injection and lasted 2 days
DIZZY; SICK; HAVING CHILLS; THROWING UP; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose was not reported, administered on 2022 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced dizzy, sick, having chills, and throwing up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from throwing up, having chills, dizzy, and sick. This report was non-serious.
Information has been received from the authors in a published literature article, regarding a 3 year old male child. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, at the age of 20 months, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, strength, frequency, route of administration, lot number and expiration date were not provided) in the right arm for prophylaxis. On unknown date, at age 3 years 3 months, the patient went to the emergency department because of lower back pain and a new rash of 3 days duration. The rash consisted of around 25 vesicles located to the left of the spine along dermatomes L4-S1, with a few vesicles on the left leg. He complained of pain and itchiness at the rash site and was reluctant to walk in the emergency department. He had experienced no changes in bowel or bladder function. After admission, a neurologic examination revealed no deficits, but did reveal allodynia to light touch in the distribution of rash. He had full strength in all limbs, no apparent sensory deficits and normal muscle stretch reflexes. Because a screening polymerase chain reaction (PCR) test of the rash was positive for varicella zoster virus (VZV) and the patient was diagnosed with herpes zoster (shingles). The patient was treated with acyclovir suspension for 10 days. His rash and other symptoms slowly resolved with no further complaints on an unknown date. The author considered the events to be related to the suspect therapy. The child had never had wild-type varicella nor had he been exposed to family members with herpes zoster. In follow-up, the child developed signs of asthma, but no evidence of autoimmune diseases or neuralgia. The author stated in some immunized children, virus reactivates within a few months to a few years to cause the dermatomal exanthem known as herpes zoster (shingles). Herpes zoster induced by varicella vaccination usually occurs within months to a few years after the vaccination in immunocompetent children. This is one of 3 cases from the same literature article 1901USA011678, 1902USA002563 and 1902USA002564. A copy of the published article is attached as further documentation of the patient's experience. Sender's Comments: US-009507513-1902USA002563: US-009507513-1902USA002564.
Upper right thigh, reddened and swollen approx. 3cm-5cm area around site; warm. Pt complaining of pain to touch and limps.
Dizziness - ears warm - nausea - tired, heavy head - arm discomfort - general malaise.
This was my 4th covid vaccine (original 2 pfizer doses, pfizer booster, moderna bivalent booster). I again had a very significant tinnitus flare up after this dose that started the next day. I also had tinnitus issues after dose #2 and #3. This one was the worst, and took 4-6 weeks to start to fade to the background, but I still have heightened tinnitus in my right ear that affects sleep.
MMR, Varivax, Prevnar and HIB given on 2-27-06.  Parents reported that child developed vesicular rash over torso, arms and legs and low grade fever on 3-3-06. Treated with Tylenol and Benadryl.
Dizziness, Weakness, Urinary incontinence, headache, flu like symptoms
Patient required hospitalization due to breakthrough infection. She received J&J vaccine on 03/31/21. Hospitalized from 07/25/21 - 07/29/21. Below is copied from discharge summary:   Hospital Course:    Acute hypoxemic respiratory failure on NC 2L due to COVID 19 pneumonia - dexamethasone 6 mg x 5 more days to complete 10 days of therapy - COVID 19 positive since last thursday prior to admission - patient cxr also showing slight pulmonary congestion - troponin negative, no ischemic changes seen on EKG, no typical Chest pain - pro-BNP 128 - O2 delivered at bedside    COVID 19 Pneumonia  - tested positive for COVID last thursday - CXR shows Mild cardiomegaly. Mild interstitial opacities bilaterally likely corresponding to recently reported positive COVID 19 infection. - procalcitonin 0.60 - ferritin 1557 - d-dimer 336  - lovenox 40 mg daily while inpatient   Patient is discharged in stable condition with stable vital signs. All questions regarding hospital course and plan of care after discharge have been answered to satisfaction.
The lymph node on my collar bone on the same side, the left as both doses of my vaccine. After the second dose the lymph node became more enlarged. It is the size of a marble that is still noticeable after eleven weeks. I am due to get an Ultrasound on the area to access the problem. Besides that, I just had mild headaches and tiredness for a short period. Second dose numberEL0142
Breakthrough case admission after 4 vaccines  pfizer 4/13/21 Lot# EW0164;  Pfizer 5/3/21 Lot# Ew0172;  Pfizer 8/18/21 Lot# FC3180;  Pfizer 8/21/22 Lot# FP7137
she just has scars left from it now; Shingles; This is a spontaneous report from a contactable consumer.   A 43-years-old female patient received bnt162b2 (BNT162B2,Solution for injection,Batch/Lot Number: EL9266,Expiry date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 13Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing mitral valve prolapse Verbatim: Mitral valve prolapse  she was diagnosed when she was 10 years old,unknown if ongoing herpes zoster Verbatim: Shingles she got shingles for the first time in her life when she was 19 years old. The patient's concomitant medications were not reported.On 20Feb2021 The patient experienced shingles, she just has scars left from it now on an unspecified date,she did visit her doctor with the shingles she had after the second dose of the Covid Vaccine,She says that it took her about a month to recovery. States she just had scars left from it now. The patient had not received any other vaccine within 4 weeks. Patient received no treatment for the event.The clinical outcome of the event was recovered.  follow-up #1 (PRD/SRD 08oct2021)-new clinical information was added.  No follow-up attempts are needed. No further information is expected.  Follow-up attempts completed. No further information expected.
Passed out 20 minutes after vaccination; ringing in ears, tingling feeling spreading from injected left arm to chest, black spots in front of eyes prior. Feeling of blacking out occurred several times after initial feeling/fainting. Extreme pallor. Was given place to lie down, given ice pack; given oxygen when I reported my chest felt tight; didn't feel like I was getting air.  Slowly (30 minutes) felt better. Paramedic said he had seen fainting before with first Moderna. Declined to go to hospital and symptom did not return. Severe side effects the following day and day after (fever, chills, muscle aches, nausea); pallor is gone.
I delivered a Moderna booster to this individual and after doing so, recognized he had received four vaccinations already. He had no adverse effects at the time of vaccination.  I notified the patient and staff at the adult family home that it occurred and advised them that no action was necessary unless he developed concerning symptoms.  Our process is to verify doses at time of registration before the day of vaccination.  We also check the cards at the site. None of our staff caught that he was already up to date until after I administered the vaccine.
No adverse event noted, vaccine administration error. Patient came in for COVID-19 vaccine on 12/09/21 @ 16:30. Patient received a dose of the Pfizer, 5-11 year-old dose, but patient was 12 yr 11mo at time of vaccine administration. Patient waited for 15 minutes in waiting room after receiving vaccine, no adverse events/reactions.
Developed rash/bruising around 4/12/21 and found on 4/16/21 to have pancytopenia, now confirmed to be aplastic anemia via bone marrow biopsy. Of note patient had bloodwork on 4/22/21 which showed completely normal CBC.
Started to have floaters in my right eye approximately 1 - 2 hours post shot. Eventually went to eye doctors like I had after the first dose in February 2021, and had more retinal tears. This cannot be a coincidence since I have never had these issues prior to the shots.
c/o complaint of lower back pain starting june0821 following getting 1st moderna shot with neck and eye pain following the next day  , pt states pain with movement of eyes and neck with lower back pain that radiates up.
Less than 24 hrs p/recving vax, pt vomitted, aspirated & had appr 15-20 seconds apnea; in hosp, pt was found to have much reflux; no apnea since pt started med tx;
Red, hardened lump around right upper thigh. Red splotchy rash around both upper thighs.
Baby taken to Emergency room after temperature was 105. ER temp was 104.8. Heart beat was 250. After IV fluids and Tylenol, fever and pulse lowered to 102. Rash followed 4 days later after fever gone.
Information had been received on 07-AUG-2017 from a female patient (age unknown) who reported that she was participating in the class action lawsuit against Merck. On 07-APR-2007, patient was administered ZOSTAVAX (dose, lot#/expiration not reported) by an anonymous physician to prevent shingles. In 2015 (exact date unspecified), the patient developed shingles which seriously affected her eye and cornea. Patient's present status was not recovered. No further information available.  Upon internal review, shingles which seriously affected her eye and cornea was considered to be a medically significant event. Additional information is not expected as patient refused to provide contact details.
Pt had a vasovagal response to the vaccine. It happened right after administration. Patient started shaking and closed his eyes. Just a few seconds later he woke up and said something along the lines of, "Oh did I pass out?" I caught him in my arms before he could fall to the floor. The same response where he started aggressively shaking and eyes closed happened a few seconds later. His legs straightened out and his head was headed backward. Again I caught him and stabilized him. Afterward, my 2nd pharmacist stopped over and spoke with him. He seemed to be feeling better, but to ensure the same reaction wouldn't happen again, we had him wait 30 min instead of the standard 15. He sat in his chair and did not have any issues. We offered food but he was not interested. I spoke w/ him again this afternoon via phone and he said he was doing fine. Pt said he has had this type of rxn before w/ previous vaccines.
Besides chills and body aches, which was expected, Bruising around ankles, along inside of left leg.  Bruising disappeared in several hours.  Chest pain began 2 days later and lasted for 48 hours.
temperature excursion at negative 5.1 degree Celsius for 12 minutes and a low of 1.3 degree Celsius for 10 minutes with no reported adverse event; vaccine administered post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11 years old male patient who was administered diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] post excursion which was at negative 5.1 degree Celsius for 12 minutes and a low of 1.3 degree Celsius for 10 minutes 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 meningococcal vaccine and hpv vaccine.  On an unknown date, the suspect diphtheria-2/tetanus/5 AC pertussis vaccine was exposed to a temperature excursion at negative 5.1 degree Celsius for 12 minutes and a low of 1.3 degree Celsius for 10 minutes with no reported adverse event (product storage error).  On 30-Aug-2022, the patient received a0.5 mL dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine (formulation and strength not reported; lot U7461AA, expiry date: 12-Jul-2024) via intramuscular route in the right arm for prophylactic immunization.  On 30-Aug-2022, (latency: same day) the patient was administered diphtheria-2/tetanus/5 AC pertussis vaccine post excursion with no reported adverse event (poor quality product administered).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  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 guidelines. 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.; Sender's Comments:  General 01266747: Daptacel 01266903: ACTHIB 01266768: ACTHIB 01266921: ACTHIB 01266924: MENACTRA 01266780: ADACEL 01266792: ADACEL 01266974: ADACEL 01266976: ADACEL  01266978: ADACEL  01266980: ADACEL  01266982: ADACEL  01266983: ADACEL  01266985: