chrisvoncsefalvay/vaers-outcomes huggingface dataset:
open sore in her nostril that keeps bleeding; open sore in her nostril that keeps bleeding; This spontaneous case was reported by a consumer and describes the occurrence of NASAL DISCOMFORT (open sore in her nostril that keeps bleeding) and EPISTAXIS (open sore in her nostril that keeps bleeding) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A,) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced NASAL DISCOMFORT (open sore in her nostril that keeps bleeding) and EPISTAXIS (open sore in her nostril that keeps bleeding). At the time of the report, NASAL DISCOMFORT (open sore in her nostril that keeps bleeding) and EPISTAXIS (open sore in her nostril that keeps bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 12-NOV-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
The nurse noted swelling to the size of an orange at the site where the vaccine was administered ( right upper sub-q area).  The physician assistant was notified and the patient received Ibuprofen 800mg every 8 hours for a localized reaction.
Information has been received from a physician concerning a female patient over 60 years old was vaccinated with 0.65 ml dose of Zostavax (Merck). Four days after vaccination, patient experienced shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
I have received 2nd period that month ( April) MY first period  finished on 4/9/21 and then I got another period on 4/19/21. 5 days after getting my first shot of vaccine( pfizer)
blood clots in her brain; Auto immune; Diagnosed with lack of oxygen to her brain; Brain fog; Cognitive issues; This is a spontaneous report from a contactable consumer (patient's grandson) from a Pfizer Sponsored Program. An 80-years-old female patient (reporter's grandmother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) first dose via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, and second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation (at the age of 80-year-old). The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date reporter stated, grandma had blood clots in her brain, had brain fog, and was diagnosed with lack of oxygen to her brain. The patient also had auto immune and was having cognitive issues. The patient was 80 and was perfectly healthy and then this happened months after the two doses of the Pfizer Covid vaccine. The patient underwent lab tests and procedures which included lack of oxygen: lack of oxygen (Diagnosed with lack of oxygen to her brain). The outcome of event was unknown.    Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2
Pt recvd vax 11AUG92 & devel t103 ax 13AUG92 w/no addtl sx; 18AUG92 t103.6, irritable, cough, tachypnea, no appetite; cxr revealed bronchitis; lymphocytosis, anisocytosis, poikilocytosis, polychromasia, sperocytes, schistocytes, basophilic
Pt was given Hep A peds 1 ml by mistake - he was to get Hep B 1 ml.
patient was given a dose 28 days after vial of 10 doses was opened with no AE; Initial information was received on 04-Nov-2021 regarding an unsolicited valid non-serious case received from a health care professional.  This case involves a male patient (unknown age) who was received a dose 28 days after vial of 10 doses was opened POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) (Expired product administered).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 11-Sep-2021, the patient received a first dose of suspect IPV (VERO) (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  It was reported "Vial of Polio was opened and patient was given a dose 28 days after vial of 10 doses was opened. Office wants to know what to do."  It was unknown if the patient experienced any additional symptoms/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 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.  There will be no information available on the batch number for this case.
Fever 101 degrees F, muscle/joint aches, Advil to help alleviate aching, fever decreased to 9.8F next day, debilitating aches for 2 days.
I received the first of three doses of Pfizer vaccine on 5/17/2021.  I then experienced amenorrhea until 8/11/2021.  My LNMP had been 5/20/2021.  I took multiple pregnancy tests, which were negative.  My period then returned and was heavier than normal and also came more frequently.  This went on for months.  I went on to receive two additional doses of the Pfizer vaccine, and, I am now suffering from amenorrhea again.  My last menses was May 2,2022.  I started to experience severe hot flashes and moodiness, and felt lousy.  Bloodwork revealed elevated FSH, LH, and low normal estradiol.  I spoke with my midwife who stated she has seen this as a result of the COVID-19 vaccine.  I have had regular, healthy menstrual cycles my entire life, until I received the vaccine.  I am now taking Progesterone to try to reset the menstrual cycle, however, it has been unsuccessful to date.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 01-AUG-2014, the patient was vaccinated with PROQUAD (Merck) (dose strength and route was not reported) (lot # J002302 and expiry date: 22-AUG-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Tingling/burning to back of neck radiating up into head, weakness. Started 2 days - after vaccine - still occuring at day 9 after vaccine.
Body went stiff and then went limp, he was unresponsive for about 10 minutes, during which time his limbs were also jerking.
patient came down with Shingles. Was treated with gabapentin and acyclovir. 01/21/2009 Office note received from PCP DOS 1/14/09 with dx: Shingles outbreak.  Pt had Zostavax vaccine 5/1/2007. Pt noted rash with general malaise and arthralgias. Scattered vessicles on R chest wall in mid-thoracic dermatome distribution. Tx: Acyclovir and Neurontin
Heart Palpitations, fatigue and chest pain starting after 4 hour stint of severe chills and body aches 3 nights after administration of the 3rd shot (moderna).  Chest pain and heart palpitations have remained constant over the past four weeks.  Seeking follow up with cardiologist next week.
Pain, numbness in anterior upper extremity (opposite from vaccine administration)  Symptoms started 3d following vaccine administration  Remained persistent and without change for 1mo before seeking treatment
At 10:30 achiness, 1-2 hours later chills, took Tylenol. 15:00 temperature of 102 with achiness, stiffness all over. Started stiffness upper body and worked down, cough, when breathed pain in chest. These symptoms continued 3 days worsened in late afternoon and late evening. Day 4 and 5 night sweats, day 6 continue stiff neck.
feels very sick; bad headache; so weak; so sleepy; belly ache; shortness of breath; nausea; This is a spontaneous report from a contactable consumer (the patient, reported for herself). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry dates were not provided), via unspecified route of administration, on 26Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had the first dose of Pfizer COVID vaccine on 26Mar2021, initially patient was fine but now (unknown date in 2021) feels very sick, bad headache, so weak, so sleepy, belly ache, shortness of breath and nausea the last 3-4 days and patient was not getting any better. Patient took tylenol but it did not work. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No additional AE reported; PROQUAD was administered after a temperature excursion; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 14-SEP-2021, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD) 0.5 milliliters (mL) as prophylaxis (route of administration and anatomical site of vaccination were not reported; lot number T025509 has been verified to be valid, expiration date reported and established as 23-JAN-2022). The vaccine was exposed to a temperature excursion of 6.9 degrees Fahrenheit during a time frame of 48 minutes (product storage error). There was no previous temperature excursion. No additional adverse event (no adverse event) was reported.
This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. No Medical History information was reported.On 13-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered too early) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to US-MODERNATX, INC.-MOD-2021-128469, US-MODERNATX, INC.-MOD-2021-138320 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128469:cross link US-MODERNATX, INC.-MOD-2021-138320:Crosslinked case of reporter- Different patient
cried more than usual w/shot/mom; wouldn't walk on leg; by 430PM same day pt wouldn't stand on leg; family MD called; MD dx allergic reaction & adm to hosp for overnight observation;
Left arm swollen at deltoid, circular red, warm area 7 cm, circum. 32 cm left arm, 29 cm right arm circum. Also had Tdap in right arm, flu shot in left arm.
Patient reports feeling lightheaded after receiving her first dose of pfizer vaccine. Vital signs taken, BP 162/78, slightly elevated, no other concerns. Patient refused second set of vitals or any other care, refused any transport. Patient left by self.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.     On 02-Apr-2022 at 10:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 10:58 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date'). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date') outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient received second booster dose. Patient ethnicity reported. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. No treatment information was provided   This case was linked to MOD-2022-542869 (Patient Link).
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In February 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
pt had wheezing w/subjective tightening of airway;pt given epi;
Throat started to close up, as well as started to itch. The reaction lasted 30mins before giving 2 benidrill for reactions. After 15 mins her reactions started to die down.   Advice patient to bring her epi pen next visit as well as taking zertic before/after the next shot.  Waiting the time to see if there is any reactions as well.
Flushed, glassy eyes, itching, bright red, swollen face. Patient received 25mg of Benadryl by mouth. 1 hour later, patient's symptoms had not improved, patient received 25mg of Benadryl intramuscular. Patient's symptoms still had not improved, patient was seen at local emergency department where patient received 10mg Decadron intravenous. Patient was discharged home with orders to continue over-the-counter Benadryl and Prednisone 50mg times five days.
pt recv vax & exp pain @ site of inj;6 days post vax a small bruise was noted @ inj site;pt recovered;this is 1 of 12 pt from this site to have an adverse rxn;
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient. This refers 28th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Patient had a mild reaction to the first injection. There was no apparent distress upon arrival in parking lot. At 15:30 the patient wants to leave and denies complaints with no apparent distress. The patient is instructed to continue medicine if necessary and if conditions worsen go to the ER.
Felt numb, freezing, felt like he could not breathe, very weak, sore over night.
Almost four weeks after receiving the Moderna Booster, I woke up with my arm in serious pain which I couldn?t move. The next day both of my wrists were in serious pain. A week later, both of my hands had severe numbness, tingling, and burning in my fingers. Days later, I began to itch from head to toe. Soon after, I began to have numbness, tingling, and severe burning shocks in my toes and feet. I?ve never had any health problems before. I?ve seen a Neurologist, a pain management doctor, as well as a chiropractor that offers neuropathy treatment. All three doctors cannot find any other reason that I would be suffering all of this pain all at the same time other than a side effect from the Moderna booster I had in October of 2021. I am still suffering with these pains. I am receiving neuropathy treatments which costed me $10k. These treatments aren?t guaranteed to work, but there isn?t any other option as doctors cannot find another reason as to why this is happening to me. I am only 40 years old.
Fever 101.3, stomach pain, headache.  Pediatrician contacted, cracker and Ibuprofen 200 mg given.
MIS-C diagnosed along with a positive Covid infection.  She went into shock from the MIS-C and was put on oxygen due to breathing difficulties.  She was eventually treated with IVIG and made a complete recovery.
Shaking episodes. She would shake for a few seconds  then a few seconds later there would be another episode, then a break then another, so they would come in clusters. Her eyes would be at half mast. The next time she got the vaccination her leg swelled up and sore and a rash that lasted for a month.
5mins post vaccination, pt c/o HA, "feeling colld all over", CP.  Per the RNs, the patient was anxious before getting her third dose shot today.   10:27 am Rapid response called due to tachypnea dizziness and feeling uneasy. Initial Assessment: Airway - Patent Breathing WNL, but 02 sats RA 88%, attempted to place 02 supplement, 02 sat up to 99 to 100%,  Circulation - pt warm, pt cc "feel cold all over", "little neck tightness" Disability - cc slight headache, and chest pain  FSBG: 168  10:28 am  Vitals 210/129, HR 146, RR 24 Pt refused ativan and benadryl.  Pt requests blanket. 10:30 am Vitals  BP 210/129, HR 138,  10:32 am Called 911 There was no wheezing.  No swelling of the face.  No swelling of the neck.  No rash.  Provider did not think this was a true anaphylactic reaction.  Therefore epinephrine was not given. 10:34 am Vitals BP 142/93, HR 122, 02 sats 100% RA  10:38 BP 168/146, HR 102 10:42 am BP 165/97, HR 108 Before the EMS arrived, her symptoms have subsided. 10:48 EMT dc w/ pt to take to ER. Pt belongings pink purse and shoes w/ pt, and cellphone.   10:50 Possible pt mask left behind, placed in baggy w/ pt ID, placed @ Front/FILE.    In ED, The patient is a 60-year-old woman with history of asthma who presents with acute anxiety and panic after receiving vaccination.  Patient received the COVID-19 booster injection this morning.  The patient within the last hour developed cute onset of feeling panicked and anxious.  She did have some shortness of breath.  The patient denied any rash or throat swelling.  The onset of symptoms was sudden and the symptoms were severe.  The symptoms spontaneously improved without particular treatment. The patient has not had reactions in the past. The differential diagnosis included was not limited to panic attack, vaccine reaction, no sign of anaphylaxis.   The patient was evaluated and treated in the emergency department.  The patient has stable vital signs.  The patient was discharged in stable condition with follow-up recommendations outlined in the discharge paperwork, as well as detailed return precautions.