chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 7 year old female child who on 04/30/1997 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. On 01/09/2002 the child developed a rash which was classified as chickenpox. On an unspecified date the child recovered. It was noted that the child was exposed to her sibling (WAES0201USA02950) who developed chickenpox 12 days earlier. Another sibling (WAES0201USA02951) also developed chickenpox following exposure to varicella virus vaccine live. No further info is available.
09/01/06 pt call with c/o decreased ROM in L arm 5 days after injection administration to current date. Tx with Naproxen x 10 days and Tylenol #3.
Booster; had a stuffy, running nose; had a stuffy, running nose; cough; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunisation; Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; NASAL CONGESTION (non-serious), RHINORRHOEA (non-serious), outcome "recovered" and all described as "had a stuffy, running nose"; COUGH (non-serious), outcome "recovered", described as "cough"; FATIGUE (non-serious), outcome "recovered", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nasal congestion, rhinorrhoea, cough, fatigue.  Additional information: The person received a booster dose and noted the following day was tired and had a stuffy, running nose and a cough. Recovered in 2 days and took a COVID-19 test. Prior to vaccination, the patient was not diagnosed with COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
local injection site reaction. red circle bump around injection area. painful for patient lasting minimum 2 days after she received shot. red area getting a little bigger and not clearing up.
Discharge Provider: MD Primary Care Physician at Discharge: MD  Admission Date: 1/26/2023  PRESENTING PROBLEM: Shock (HCC) [R57.9] Encephalopathy [G93.40] Acute on chronic respiratory failure, unspecified whether with hypoxia or hypercapnia (HCC) [J96.20] Acute on chronic anemia [D64.9] Pressure injury of sacral region, stage 4 (HCC) [L89.154] Septic shock (HCC) [A41.9, R65.21] Enterococcus faecalis infection [B95.2]   HOSPITAL COURSE: 73yo M with hx multiple CVAs, chronic trach/PEG (not vent dependant), DMII, non-verbal, diastolic heart failure, Afib (Xarelto), resident who was admitted 1/26 with acute hypoxic respiratory failure and shock.  COVID +, suspected bacterial sepsis, RIGHT sided PNA (recently PSA PNA).  Placed on ventilator, given 3 L IVF with ongoing hypotension needing norepinephrine.  Empiric Vanco and Cefepime were started.  NE off 1/27. Enterobacter 1/2 BC, unclear if true bacteremia.  Palliative care c/s 1/27.  Hemoptysis 1/27, bronch without source, TXA Nebs x24hrs, resolved.  Heparin gtt started 1/29 for afib while holding Xarelto. Limited ECHO NEG vegetation but tricuspid and pulmonic valves not seen, considering TEE.  Worsening AKI, Renal US NEG, renal consulted.  T-piece since 1/28.  Stento growing in sputum felt to be colonizer. Renal function continued to worsening with decreasing urine output.   Case conference with family (son, daughter), guardian, hospitalist, Palliative Care Dr. on 1/30. Hospice informational meeting was arranged and family and guardian decided to make patient comfort measures.  Guarding decided initially to continue tube feeds as family was requesting.  Patient with large episode emesis with aspiration 2/10.  Tube feeds discontinued. Patient with seizure life activity switched to versed and fentanyl. However, did not require boluses and placement being sough however suctioning needs to high. He was transitioned to humidified air by flow meter. Patient noted to be hypothermic and bradycardic on 2/20 while seeking placement at facility switched to prn pushes.     Death Pronouncement: Called to patient's bedside to pronounce that patient has died. Patient was DNR/DNI/Comfort care. On bedside exam no spontaneous movements were present. There was not response to verbal or tactile stimuli. Pupils were mid-dilated and fixed. No breath sounds were appreciated over either lung field. No carotid pulses were palpable. No heart sounds appreciated.   Patient pronounced deceased 2/22/2023 at 05:09
HEADACHE; DIZZINESS; This spontaneous report received from a patient concerned a 67 year old male. 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: 103AZ1A expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dizziness. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and the outcome of headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210702102 and 20210701921.
2nd Dose of Moderna Vaccine administered on 9/6/21 from Lot #011A21A expired 8/16/21.  *Site leadership consulted with the Moderna and received the below confirmation: * If the dose given in error is the first dose, a second dose should be administered 28 days later. If this dose is the second dose, the series is complete and no additional doses are needed.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-OCT-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot#J010613, expiration date 11-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 48, 1 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Initial and follow-up info has been received from a physician concerning a male with no known drug allergies and no significant past medical history who on 05/24/2001 at 15:00 was vaccinated in the left leg with the first dose of varicella vaccine. Concomitant therapy on 05/24/2001, sometime in the afternoon, included the first dose in the right leg of Prevnar. It was reported that the pt was recovering from rhinosinusitis at the time of vaccination. The pt also received the first dose in the right arm of MMR vaccine on 04/30/2001 and was receiving Zithromax, Tussi-12, and Fer-in-sol. On 08/21/2001 the child presented to the physician's office with vomiting, fever (102.9 deg. F), and a vesicular rash starting below his left shoulder and ending on his left chest. The rash extended to the child's back, followed a skin dermatome and didn't pass the midline. The physician reported that the child develoed herpes zoster on 08/17/2001. The child was treated with Motrin and calamine lotion. It was noted that the child did not have a post vaccination rash within 42 days of vaccination and that there was no known exposure to wild type virus or shingles. A specimen from a vesicular lesion was submitted on 08/24/2001 for PCR analysis. Follow-up info received indicated that the specimen was inadequate to process. Subsequently, the pt recovered from his experience. No further info is available.
Sedation, Myalgia, Arthralgia, Chills, pain at injection site Narrative:
Fever 102, body aches, chills for about 2 days.  Day of vaccine-no pain. Did a round of golf in the evening.  Painful next morning when woke up.  Arm is painful when try to lift at the shoulder.  Pt states "feels like muscle is gone". Has not been able to do her normal work out activities since vaccine-pt is normally very active.
Pt c/o "feeling mean" "unreasonable" unable to control actions.  C/O homicidical ideation's for 1st 24hrs.  2nd 24hrs c/o uncontrollable crying-sport resolved-reported to Dr. on 12/6/05.  Pt feels that it is r/t rabies vaccine.
Patient reported swelling around vaccination site about a week after receiving her first COVID vaccine. She said it has gone down and is almost back to normal. She did report that she normally has mild swelling around vaccination sites for other vaccines as well.
compression fracture on her back; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on Mar2021 (lot number was not reported) as a single dose for COVID-19 immunization. She's due to take her 2nd dose of vaccine on Tuesday, 06Apr2021. She could not recall when her 1st dose was which was 4 weeks to the day on Tuesday. Medical history and concomitant medications were not reported. The patient had a compression fracture on her back last week on 2021, she's due to take her second dose of the vaccine on Tuesday. She's currently taking pain medications. She's wondering if she could still take her second shot as scheduled as she's aware that she could not take any medications along with the vaccine like pain relievers (Tylenol or Advil). The outcome of the event was unknown.  Information about the lot/batch number has been requested.
Pain where I had the vaccine; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old (also reported as 72-year-old, pending clarification) male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration in the left arm, on 20Jan2021 09:00, at single dose, for COVID-19 immunization, at a public health department. Medical history included diabetes, blood cholesterol abnormal (reported as cholesterol) and blood pressure high (reported as high pressure, pending clarification). The patient had no known allergies. Concomitant medication included amlodipine, atorvastatin, cyclobenzaprine, and losartan potassium (COZAAR). The patient did not have other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient reported he had "pain where I had the vaccine" on 20Jan2021 at 14:00. No treatment was given for the events. The outcome of the event was not recovered.
heartburn; This case was reported by a consumer via call center representative and described the occurrence of heartburn in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced heartburn. On an unknown date, the outcome of the heartburn was recovering/resolving.   It was unknown if the reporter considered the heartburn to be related to Shingrix.  Additional details were provided as follows: The patient stated that approximately 2 days after receiving the vaccine, she developed heartburn. The patient did not consent to follow up. The patient did not provide any additional information.
pt says he had chills the day of taking the vax.  The next day he had extreme fatigue and was very sleepy not being able to stay awake.  Pt says this vax has reset his internal time clock.  He gets sleepy around noon time but at bed time he is feeling like he could run a 5K.  He will get groggy in the daytime but cannot sleep at night.  He gets daily episodes of weakness in his legs where they feel like rubber.  He stays light headed and gets dizzy spells on occasion.  Pt will discuss w/ his PCP at next visit.
13.5 hours after second dose, fever chills headache (temp 101F)  4 days after second dose vomiting, diarrhea for 24 hrs
Patient received dose 1 of Moderna COVID-19 vaccine.  Shortly after administration, approximately 5 minutes, patient stated she felt tightness in her chest.  Immediate evaluation of pulse was normal, no diaphoresis, no shortness of breath, no radiating pain down left arm, no rash or dermatologic manifestations noted upon initial exam.  Took patient outside for fresh air.  Immediately notified onsite MD and retrieved golf cart to take her for evaluation in our onsite clinic.  BP performed and reported as normal.  EKG performed and reported as abnormal.  Physician notified EMS and they took her to our local ED.  .
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. PMH include chronic A.Fib, Hypertension, Hyperlipidemia, DM-II, Asthma, Anemia, Angina, Osteoarthritis, Pulmonary Fibrosis, Depression, respiratory failure, CKD, angina, vitamin d deficiency. Pt was 91 years of age.. Patient came to hospital on 4/17 with a cc of sob and found to be hypoxic. Diagnosed with bacterial pneumonia. placed on hospice on 4/21.
No adverse event; Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 22-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine (more or less 170 - monovalent and 20 bivalent) which were beyond the 30 day beyond use date).    Concomitant product use was not provided by the reporter. More or less 170 - monovalent and 20 bivalent doses had been administered which were beyond the 30 day beyond use date. Vaccine administered on 23-Feb-2022 with lot number 042J21A after 30 days BUD date which was 17-Feb-2022. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non significant Follow up Appended; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Narrative:  COVID infection following COVID vaccine series 02/16, Pfizer, dose #1 03/09, Pfizer, dose #2 12/23 COVID swab, result: detected 12/23 pt cc: chills, diarrhea, fatigue, fever, headache, myalgias, rhinorrhea, sore throat exposure: unknown 12/23 SARS-COV-2 Variant Sequencing: pending
Fever 2 days, severe large, red rash 1 wk, persistent itching and pain to date.
Patient began shaking while in car. Mom pulled over and noticed her upper and lower extremities shaking lasted less than 15 minutes. Went to ER, ADVIL given, and diagnosed with febrile seizure.
a 17 year and 11 month old patient received Menactra first dose on 2013, second dose on 07-Jul-2018 and third dose just now; Initial information received on 02-Jul-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2019SA182073.  This case involves a 17 years old patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] first dose on 2013, second dose on 07-jul-2018 and third dose just now (lot number and expiry date not reported via unknown route in unknown administration site).  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 extra dose administered.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Received Flu shot then 20-30 minutes later got a rash on the neck, back and about 1/2 later it moved to my chest and shoulders.
7/11/21: Nausea, Muscle Pain, Back Pain, Fatigue 7/12/21 - present, onset of irregular heartbeat (at least 1-5 occurrences/hour) 7/17/21-7/18/21 afternoon: Irregular heartbeat and lightheadedness, back pain, nausea, fatigue, stomach pain in am/ Back pain, nausea, fatigue, stomach pain, fever, chills, body ache/muscle pain from 4 pm after 7/18/21 Negative Covid Result (urgent care - rapid test) 7/19/21: Irregular heartbeat and lightheadedness, back pain, nausea, fatigue, stomach pain, fever, headache, restlessness, body ache/muscle pain 7/20/21: Irregular heartbeat and lightheadedness, back pain, nausea, fatigue, stomach pain, fever, body ache/muscle pain, congestion
Patient was given PEDIARIX vaccine in (R) thigh on 6/15/12 during routine physical. Developed redness, swelling & tenderness at IM site. Patient was seen in ED on 6/17 for treatment.
swelling, pain, warm to the touch, and redness.  Pt was assessed by provider today.
myocardial infarction and possible myositis 2 days after adacel vaccine 11/1/07-records received for DOS 8/19-8/22/07- DC DX:Acute coronary syndrome. Presented to ED with 24 hour history of midsternal chest pain.  Received a tetanus shot one week prior and it is conceivable that this may be an inflammatory myocarditis. Per 60 day follow up: Patient has not returned for follow up after hospitalization.
Please be advised that we had an individual come and was administered what we were led to believe was his 1st dose of Pfizer Vaccine on 7/30/2021. On his intake form and during his verbal questioner prior to the injection, he advised that he had not received a COVID-19 Vaccine.  While inputting his data he prepopulated in the system and under vaccinations we identified that he actually did in fact receive a previous Pfizer dose 1 on 12/22/2020 and a Dose 2 on 01/08/2021. I contacted  and they advised to follow-up with the patient to check on his/her wellbeing and assess for any adverse events and/or reactions. This is considered an administration error, due to 3rd doses not being authorized, a report to VAERS will need to be submitted. I contacted the patient and he advised that the information we found was incorrect, he advised that he had scheduled but never received the vaccine, and that he would contact the healthcare facility.
This spontaneous report was received from a Medical Assistant referring to a 4 month old patient. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 23-MAY-2017, the patient was inadvertently vaccinated with a dose of VAQTA 0.5 ml, intramuscularly, lot # M022924, expiration date 24-JAN-2018,  for prophylaxis. No adverse effects were reported. A product quality complaint was not involved. Additional information is not expected because the reporter refused additional contact.
No adverse event; one dose of properly stored but expired VARIVAX; This spontaneous report was received from a registered nurse and refers to a 42 year old patient, of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, and historical drugs was not provided.  On 18-JUL-2019, the patient was vaccinated with a properly stored but expired varicella virus vaccine live (oka/merck)(VARIVAX) 1 dosage form, lot # N017701, expiration date on 09-JUN-2019 (route and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent lot # N032756 and expiration date 05-AUG-2020. No adverse effects were reported.
Vaccine administration yesterday. Today she feels like she is getting a cold (sore throat). No trouble breathing, fever. Asked if she could take COLD-EEZE. 1-18-16 - pt. called today feeling back to normal but noticed rash on back. No pain. No itching. Encouraged her to see PMD.
Shingles Outbreak; Rash; Back Pain; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles Outbreak), RASH (Rash) and BACK PAIN (Back Pain) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HERPES ZOSTER (Shingles Outbreak), RASH (Rash) and BACK PAIN (Back Pain). The patient was treated with VALACYCLOVIR [VALACICLOVIR] for Herpes zoster, at a dose of 1 dosage form. At the time of the report, HERPES ZOSTER (Shingles Outbreak), RASH (Rash) and BACK PAIN (Back Pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The consumer was taking "Valacyclovir", an antiviral medication, as advised by HCP to try to alleviate the symptoms.