chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd 1 dose of Engerix-B & @ the beginning of JUN & 12JUN92 viral infection, diarrhea, nausea, vomiting & inc liver enzymes; 13JUN92 dizziness; 19JUN92 green nasal discharge & coughing;
PUNCTURED VIAL DOSE ADMINISTERED; WRONG TECHNIQUE IN DRUG USAGE PROCESS; This spontaneous report received from a health care professional concerned a female 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: 1822809 expiry: 07-MAR-2022) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-SEP-2021, the patient experienced punctured vial dose administered. On 30-SEP-2021, the patient experienced wrong technique in drug usage process. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vial dose administered and wrong technique in drug usage process was not reported. This report was non-serious.
rash; low grade fever; swelling; nausea; headache; fatigue; 12 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (12 weeks pregnant), RASH (rash), PYREXIA (low grade fever), SWELLING (swelling) and NAUSEA (nausea) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Aug-2021. On 14-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (12 weeks pregnant). On 15-Jan-2021, the patient experienced RASH (rash), PYREXIA (low grade fever), SWELLING (swelling), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue). On 14-Jan-2021, EXPOSURE DURING PREGNANCY (12 weeks pregnant) had resolved. At the time of the report, RASH (rash), PYREXIA (low grade fever), SWELLING (swelling), NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details provided as Tylenol and Benadryl.
paresthesia in hands, shortness of breath  Narrative:  First dose of Pfizer COVID19 vaccine administered 2/13/21. No  adverse effects documented. Second dose received 3/5/21. On 3/9/21, patient presented to ED with SOB, cough, and wheezing. Symptoms and finding consistent with COPD exacerbation with bilateral bacterial PNA. Also found to have new  onset atrial fibrillation with tachycardia. Unclear if any respiratory symptoms were related to vaccine. Patient was admitted and transferred to hospital with diagnosis of COPD exacerbation and AFib with RVR. Per provider notes, no indication that an allergy was suspected. Patient was treated methylprednisolone, ceftriaxone, and azithromycin for PNA as well as diltiazem and apixaban for new onset AFib. Was discharge 3/11/21. Patient presented 4/1/21 at cardiology  follow-up appointment and reported he developed paresthesias  after second Pfizer dose. Right hand worse than left. Stated he now has difficulty holding a pen. No documentation of this during admission. Unclear if related to vaccine, no treatment documented. Further work up pending at time of reported.
After the first dose shortness of breath, tight back and headaches. Not associating it with the vaccine I took Sudafed and used my inhaler. This was not my typical asthma symptoms. It improved after @3 weeks. About 2 days after the second dose shortness of breath, tight back, unable to take full breaths using inhaler again. 9/21 left work to see Dr. Because it was too much not being able to breath. Given steroid inhaler, prednisone and continue rescue inhaler.  Increasingly worse I had massages on 9/23 and 9/25 to help loosen the tight back muscles. ER visit on 9/23. Told I had low potassium, elevated WBC count likely from prednisone and an abnormal EKG. Told to F/U with pulminolgy and cardiology.  Dr office doesn't respond to messages well.  Pulminolgy 9/5 and cardiology can't see me until November. By then the symptoms will surely subside (God willing). All symptoms over last 2 weeks- shortness of breath, difficulty breathing, headaches, joint pain, light headed/ dizzy, infrequent palpitations, sweaty spells, frequent adrenaline like rushes in my chest, brain fog, rapid hrt beat (watch alerting A-FIB never have had this before) and left face numbness and tingling (9/30). I feel like no one thinks this is an issue!
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (still has pain in left arm), INFECTION (He was given medication for infection), LYMPHADENOPATHY (lymph nodes in both arms are swollen) and ARTHRALGIA (pain at the end of the arm, wrist and thumb) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 030L20K) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (still has pain in left arm) and LYMPHADENOPATHY (lymph nodes in both arms are swollen). On an unknown date, the patient experienced INFECTION (He was given medication for infection) and ARTHRALGIA (pain at the end of the arm, wrist and thumb). At the time of the report, PAIN IN EXTREMITY (still has pain in left arm) and LYMPHADENOPATHY (lymph nodes in both arms are swollen) had not resolved and INFECTION (He was given medication for infection) and ARTHRALGIA (pain at the end of the arm, wrist and thumb) outcome was unknown.            The action taken with mRNA-1273 in response to the event was not applicable.  Treatment medication included a cream for the pain. No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-072642 (E2B Linked Report). This case was linked to MOD-2021-072642 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 10-MAY-2021 contains Event added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072642:
received 3 doses of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number 27P85, expiry date 3rd February 2023) for prophylaxis.   Previously administered products included Shingrix (the patient received the first 2 doses of shingrix about 2 years ago).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received 3 doses of Shingrix, third dose was administered this year, which led to extra dose administered. No reactions reported. The reporter consented to follow up.
Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Circumstances surrounding his death are not documented in chart. Comorbidities include Hepatitis C, HTN, T2DM.
The pt had no problems immediately after injection or prior to being discovered dead in crib at 05:45 on 11/28/01. On the last check of pt at 03:00 on 11/28/01, he was laughing and playing. Death certificate indicates the child died from shaken baby syndrome (suffering from this since 5 weeks old according to the dept of health).
Initial unsolicited report received from a Nurse on 25-May-2018. This case involves female patient (gender was not reported), who was vaccinated with QUADRACEL (batch number- C5248AA, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. Medical history and concomitant medication was not reported. On an unknown date, following vaccination patient had hot red swollen more than 3 in in diameter itchy bumpy. Lab data and corrective treatment were not reported. Outcome of the events were not reported. Documents held by sender: none.
Child developed swelling of administration site (upper left arm) with increasing redness and overnight developed a target-like erythema that lasted for greater than 48 hours despite Tylenol, Benadryl, and cool compresses.  Child also became febrile with high peak early AM at 101.6 and remains approximately 99 degrees at nearing 72 hours from administration, which was minimally relieved with Tylenol alternating with ibuprofen.  Child developed significant rhinitis and upper respiratory, non-productive cough. Administering physician was notified, primary care physician was notified and phone triage and treatment were as prescribed. Child's condition is currently improving, but not yet fully resolved.
ARM TINGLING, ITCHY, WENT NUMB AT SHOT SITE.  PROGRESSED ALONG BACK AND SPREAD TO OTHER ARM, COVERED UPPER BODY, LASTED FOR 1/2 A DAY.  8 MONTHS PREGNANT.  DOCTOR CHECKED VITALS, NO BLOOD DRAWN.  SYMPTOMS GONE FOR NOW.
Bilateral tinnitus, right greater than left, developed 7 days following the second Pfizer Covid-19 vaccine and has persisted to date.   No history of tinnitus, loud noise exposures, hearing loss.
pt recvd vax 25MAy94 & pt found dead in bed 26MAY94; autopsy SIDS;
patient wished to received their second dose of Shingrix 3 years after the initial dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 01-FEB-2020 with batch number 4ME42 and expiry date 23-JAN-2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient wished to received their second dose of Shingrix 3 years after the initial dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-AUG-2023 The pharmacist wanted to know how to proceed. The vaccine administration facility for 1st dose was the same as primary reporter. VAERS details were reported for 1st dose. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
This serious case was received on 30 April 2009 from a health care professional.  A 57 year old (corrected on 05 May 2009) female patient with high blood pressure received ADACEL and TUBERSOL (lot number not known) on 21 April 2009 at 2:00 PM.  ON 22 April 2009 the patient reported a painful arm which was swollen under the armpit with tenderness.  The patient used warm compresses and MOTRIN but the pain persisted.  The patient's voice became hoarse and she developed a swollen throat at that time.  The patient saw an ear, nose, and throat physician on 25 April 2009.  She was put on an antihistamine and AVOLEX.  The patient's recovery status was unknown at the time of the report.  List of Documents held by Sender:  none.
Cardiac arrest at home, EMS performed CPR. Return of spontaneous circulation in the field after 2 rounds of epinephrine, In ED unresponsive, placed on a ventilator, required high doses epi to maintain perfusing blood pressure.  Has acute kidney injury with hyperkalemia, shock liver and severe metabolic acidosis with arterial pH 7.04. CT of the head showed early findings of anoxic brain injury. Admitted to ICU and treated with aggressively with vasopressors, bicarbonate drip, heparin drip and empiric broad spectrum antibiotics. Very poor medical and neurologic prognosis, discussed with family and patient was transitioned to comfort care and passed away on 03/21/21 at 1626
No AE/PQC reported; Expired vaccine used; Human error nurse did not check the expiration date prior to administration; This spontaneous report was received from a nurse referring to a 2-year-old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.    On an unknown date, the patient was vaccinated with the first dose hepatitis a vaccine, inactivated (VAQTA) (strength, dose, route and lot# unknown) for prophylaxis. On 01-DEC-2020, the patient was vaccinated with the second dose hepatitis a vaccine, inactivated (VAQTA) (strength: 25/0.5 (unit not reported)) 0.5 milliliter, intramuscular (IM) once for prophylaxis (lot # was S034636 and expiration date was 14-NOV-2020). It was stored at the appropriate storage condition, specified in the product label.  It was reported that the nurse did not check the expiration date prior to administration (expired product administered and product preparation error). No addition adverse events/no product quality complaint (PQC) were reported (no adverse event).
Onseto f hives within five minutes on bilateral legs, progressing to back and posterior scalp.  Some diminished within 30 minutes others remained. No respiratory distress, lungs remained clear to auscultation bilaterally throughout observation.  Observed 30 minutes prior to discharge.  Private physician contacted.No treatment necessary in this office.  Child had no further difficulties after going home.
Client fainted after administration of vaccines. Approximately 5 minutes after given was standing up and fell to floor. No apparent injury.
Hard lump at injection site first noticed at about 5pm on 1/15/21, only the size of a finger tip. It grew to a large oval 2.5 to 3 inches across, that was hard an painful within 3 hours. It also became redder, darker, and itchier as it grew. A health professional was contacted to discuss need for treatment. He had been concerned that it may be an infection as he thought it was too long since the injection to be a site reaction. Patient was seen that night & told it was an adverse reaction. The lump grew over the next 3 days. On 1/20/21, patient noticed that the "lump" area was softer and faded, but now had a darker pink circle around it that was raised and hard, about 2-3 cm wide. This took over a week to fade. Patient spoke to another ED provider on 1/20/21, and was told it had been an "arthus reaction" to the vaccination.
covid vaccine breakthrough case  dose 1 Pfizer 5/11/21  EW0179
This study case was received from the investigator in a trial on 18 February 2013. A 24-year-old male subject had received ACAM2000 on 06 December 2012 and 18 days later he was diagnosed with acute idiopathic pericarditis. At 20 days post vaccination, he was diagnosed with Other, carditis. On 21 December 2012, ECG results were abnormal. On 22 December 2012, troponin I results were abnormal (3.07 ng/mL) and echocardiogram was normal. On 26 December 2012, an MRI of the heart was normal. Lumbar puncture (spinal tap) and MRI of the brain and spinal cord were not performed. The subject previously received an injection of the following vaccines on 27 November 2012: TYPHIM VI (ViCPs), Anthrax 1 (other manufacturer), and Influenza seasonal (manufacturer unknown) (lot numbers, routes and sites of administration not reported). The subject has no significant medical history. Outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
I decided to check my blood pressure and it was about 190/100. The highest my blood pressure got up to 230 the same day. I went to the hospital, and they checked my EKG, which was normal. The next day they advised me to go to my primary doctor and he increased my blood pressure medication. Now it is controlled with medication.
Slight Nasal Congestion similar to COVID Body Aches Fever (100) Fatigue COVID Arm 6 days after injection
Day after vaccination, extreme pain in shoulder followed by being sick for 4 days. Pain is less, however continues in right arm daily. Loss of stregth in right hand Pain runs from shoulder to finger tips. I've seen several specialists and no one has an answer.
pt describes fatigue for several wks after getting 2nd COVID 19 vaccine (pfizer). also, he recieved Hep A/B combo vaccine + HPV vaccine 8 days after the 2nd dose of COVID19 vaccine.
Developed a small rash around the injection site on 1/8/2021. Rash increased in size and became itchy. Worse symptoms present 1/16-1/17.  Rash has begun to improve today 1/18.  No treatment at this time. - Taking OTC ibuprofen, using ice compresses, and continuing her prescribed antihistamines for allergies.
Information was received from the mother of a 16 year-old female patient who was vaccinated with a second dose of VARIVAX in approximately 2009. The date of the first dose of VARIVAX was not reported. The patient complained of bad cramps that started two weeks after the second dose and have continued for a year and one-half. The cramps were described as lasting a few hours and sometimes up to a day. "The cramps cause a lot of pain and occasionally cause the daughter to throw-up." The patient sought medical attention from a physician, and she has not recovered. This is one of two reports received from the same source. No additional information is expected.
Sore arm low grade fever week later, lymph node on arm pit was swollen and tender
Dizziness, Headache, Myalgia, Fatigue, Injection site pain Narrative:    Other Relevant History:
Fever 101.5; body aches; chills; skin sensitivity and migraines (severe and hard to treat).
Really bad breaking out of her skin; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN (she does not have her card available at this time), Expiry Date: UNKNOWN) via an unspecified route of administration on an unspecified date in 2021 (about a month ago) (at the age of 63 years-old), as a single dose for COVID-19 immunization. The patient medical history (including any illness at time of vaccination) was none. No concomitant medications (other products) were reported. Family medical history relevant to adverse events was none. The report was not related to a study or programme. The vaccination facility type reported as grocery store. The vaccination facility address was unknown. Additional vaccines administered on same date of the Pfizer suspect was none. Prior Vaccinations (within 4 weeks) and adverse events following prior vaccinations was none. On an unspecified date in 2021, the day after she got the shot, patient experienced really bad breaking out of her skin (It has been about a month since she took the first covid vaccine). The patient was not visited to emergency room and physician office. No investigation assessment. No treatment was taken, she assumed that it would go away. It was reported that action taken with drug was unknown. Patient is due to receive the second vaccine, but she doesn't know if she should get it or not. Reporter (patient) questioned about the getting second vaccine. Reporter wants to know if there have been any reports of breaking out of the skin with the Pfizer COVID-19 vaccine. The outcome of event was recovering.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 28th February 2019, the patient received the 1st dose of SHINGRIX. In March 2019, several days after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site erythema was not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The reporter was the husband of the patient. A couple of days later the patient's arm became very sore and red at the injection site. The soreness had almost resolved and it was reported to currently be a 1 on the pain threshold scale. The redness had turned pink and was still present in a 3 inch circumference on the patient's arm. The reporter gave consent to follow up.
Intermittent slurred speech, right sided facial droop, aphasia x2 days, dx'd with subarachnoid hemorrhage, possible cerebral amyloid angiopathy, worsening of baseline symptoms. Patient unable to return to independent living at her home, currently in SNF, to be placed in CBRF on discharge
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose02/25/21 2nd dose03/24/21 Diagnosed covid positive:09/14/21 Symptom onset:09/12/21 Exposure:Travel Symptoms:fever, cough,muscle aches,sore throat,chills,HA
Information has been received from a Pharm. D. concerning an adult female who was vaccinated with hep A virus vaccine. Subsequently, the pt experienced rheumatological ains. The Pharm. D. also stated that the pt recently started an exercise program and she was not sure if the pains were related to the exercise or the vaccine. The pt sought unspecified medical attention and her outcome was unknown. In follow-up, the Pharm. D. reported that after examining the pt the doctor did not feel that the pt's experience was related to hep A virus vaccine. The pt received the vaccination about six months before she started to feel the musculoskeletal pain. The doctor thought that the pain was "more likely due to other reasons." Additional info is not expected.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 11-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired in 05-Feb-2012. The patient received expired FLUMIST either on 07-Feb-2012 or 08-Feb-2012. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
the wrong  booster was administered with NO adverse events . Patient was supposed to get the Bi Valent booster and instead received the Mono-Valent booster. The patient did NOT have any adverse events.
Distal tingling x 4 extremities, swelling, erythema of posterior pharynx, able to swallow saliva, no tongue, lip  or facial swelling, heart rate 90, respirations 16, lungs clear, 50 mg of Benadryl administered IM right deltoid at 11:33 AM with good effect, transported to the Medical Center via ambulance with advanced life support capability at 11:52 AM.