chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2015US002898, is an initial spontaneous report received from a consumer on 06 FEB 2015. This report refers to a 41 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145304) intramuscularly on an unknown date. On 18 OCT 2014 (after unknown interval of vaccination), the patient experienced soreness at site, muscle pain and exhaustion. She used other arm at times due to weakness of the injected arm. She also woke up during night due to pain. The patient was planning to visit a physician. Final outcome of the events was unknown. Seriousness and causality of the events were not reported.
Started with severe cough, went to sinus infection, treated for 9 days with Antibiotic, sinus infection cleared up developed itching rash. Still have rash as of today 11/04/2015.
Shortness of breath since first vaccine; This is a spontaneous report from a contactable consumer (patient). A 39-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date of 2021 as dose 1, single (at the age of 39-years-old) for COVID-19 immunisation. Medical history included Magnetic Resonance Imaging (MRI) dye allergy from an unknown date and unknown if ongoing. Patient had no other vaccine in four weeks. Patient had no other medications/ concomitant medications in two weeks. Patient was not diagnosed with COVID-19 prior to vaccination and on an unspecified date of 2021, patient had been tested for COVID-19, post vaccination, by nasal swab test and result was negative. On 18Mar2021, patient experienced shortness of breath since first vaccine. Patient had doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit for the event. Therapeutic measures were taken as a result of shortness of breath since first vaccine and treatment included steroid. The outcome of the event was not recovered.  No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.
24 years old male presented to hospital after a fall on Nov 11.  He started experiencing weakness and numbness in bilateral lower extremities and hands that were ascending to his trunk.  He developed tetraparesis.  Had extensive workup, incluidng MRIs, nerve conduction studies. Diagnosed by Guillain Barre syndrome (AMSAN).  Had almost 16 days of hospitalization and 25 days of acute rehabiliation, still cannot stand up and walk without assistance, has severe neuropathic pain.  Received IVIG 2 courses 5 days each, steroids, Lyrica, Nortriptyline and other medications. Will need further physical therapy as outpatient.  Patient reported only being vaccinated with inactivated influenza vaccine shot at a private doctors office in mid-October, 2014, no other reported viral or other infectious disease.  He cannot recall the address and the exact address of the place, but his brother will know.  The family raised concern that this might be associated with his vaccination as he had no other medical problems, no similar family history. I am the Internal Medicine resident physician following him while he is in the acute rehabiliation unit.  I notified the patient and the family that I will report this case to VAERS.
Significant joint and muscle pain and headache and could not walk without support for 3 days.
Patient was given FLUZONE 0.25 mL at age 4 mos. Manufacturer recommends age 6-35 months of age. Parent informed. No reactions noted.
This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a improperly stored PNEUMOVAX 23, timeframe 16 hours, temperature of 34F, (strength, dose, route, and frequency were not provided) (lot# L018503, expiration date 16-MAR-2017). Concomitant therapies were not provided. The registered nurse did not reported adverse effects. No product quality complaint was involved. This is one of two reports from the same reporter. Additional information has been requested.
After adverse reaction 9-10 inch redness, temperature, rough skin, itching) to actual vaccination an extremely itchy, bumpy/uneven and scaly area developed at base of scalp on same side as vaccination.  It has lasted 1 1/2 months until I went to the doctor on Monday, 11/06/2012 and it was diagnosed as Shingles.  I was given generic Valtrex and an antibiotic to prevent infection (where I had badly scratched the area).
improperly stored vaccine; No adverse effect; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unknown.   On an unknown date the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R030804 with expiration date of 22-APR-2020, rHA, 0.5 milliliter, subcutaneous) for prophylaxis. The sterile diluent used to reconstitute the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) vaccine was stored in the correct temperature. No adverse effect was reported. The temperature excursion was 5.4 degree Fahrenheit with a time frame of 3 minutes. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved.
Had rash 2 days after the injection of COVID 19 vaccine.  Continued to have rash on both legs and back. Came to clinic and was told to discontinue the Advil PM.  Benadryl 25mg given OTC as needed for rash and itching along with Benadryl cream
Client fainted after receiving the vaccine. Client was only out for less than 20 seconds. Vitals checked and were fine. Ice packs applied and client given juice to drink.
No adverse events, but RN gave a pediatric dose of Hepatitis A to and adult.
Incorrect vaccine administered: Adult Pfizer given to a pediatric patient. No adverse outcomes reported per patients mother as a result. Advised that if anything is experienced to report to us immediately for assistance.
I had a painful, burning, itchy rash that was going down the right side of my neck, my hairline, and extended to my upper back. I was diagnosed with shingles and provided valacyclovir, gabapentin, and pain meds. Also, during my routine ultrasound, my baby had a left arm deformity in which her forearm bones were missing leaving her left hand attached to her upperarm. She also had a Congenital Diaphragmatic Hernia (CDH) and Hypoplastic Left Heart Syndrome (HLHS) resulting in extremely poor prognosis that the providers told me that terminating my pregnancy is something I needed to consider; After speaking to a support group and different specialist, I decided to terminate the pregnancy because the lif expectancy was only 2-4 days and i could not bear carrying a child only to bury the child a few days later.  EDD was OCT 2021
Starting 8-9 hours after vaccines started with fever, nausea, aches, vomiting 1 time - lasted 24 hours then resolved.  Also states flare-up of his ongoing Rosacea.
Developed flushed feeling, itch without rash or difficulty breathing. Refused medical care.
This spontaneous report as received from a nurse practitioner (N.P.) refers to an unknown number of patients of unknown age and gender. Medical history and drug allergies were not reported. On 23-JUL-2015, the patients were inadvertently vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # L000453, expiration date 06-JAN-2017, dose and frequency were not reported). Concomitant medication was not provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information is not expected as the reporter did not wish to be contacted.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillins" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cephilexon, reaction(s): "Known allergies: cephilexon". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not receive other medication in 2weeks. Patient was treated with Paxlovid from 07Jul2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Around 11 PM on April 8th after receiving the Janssen vaccine around 4:50, I woke up with intense chills, nausea and a fever.  I also experienced an intense stomach pain that came and went that would make it difficult to move without severe pain. I felt extremely disoriented and confused and had a strong headache throughout the intense period of symptoms. Around 7 AM on April 9th the next day, the symptom's severity decreased and I experienced all of the symptoms mildly along with drowsiness. On april 10th I did not experience any stomach pain, body aches, or chills but, still experienced drowsiness, intermittent headaches and a mild fever. On april 11th, drowsiness  and a headache continued. Today, april 12th, I am still experiencing a mild headache and slight drowsiness.
sweating; fever; chills; body aches and states " of course is extremely sore; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches and states " of course is extremely sore) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches and states " of course is extremely sore). At the time of the report, HYPERHIDROSIS (sweating), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches and states " of course is extremely sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment medication provided.
6JUL95 pt had 2 episodes of vomiting, fever of 104, irritability, area of swelling on rt arm was the size of a quarter; pt was seen by MD 7JUL95; tx APAP & advil q 4 hr;
1 hour following injection at 4:15pm patient experienced itching and shortness of breath at 5:15pm. Patient then went to ER.
Severe chills and upset stomach .Also. headache and burning of eyes. Eyelids lids burning.
Got the 1st Pfizer vaccine on 4/10. Started getting dizzy with vertigo and nausea 4/14. Have missed worked. Cannot stand up for more than a minute or two before the vertigo gets debilitating.  Have been in bed, dizzy, for 7 days straight.
itch; swelling; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PRURITUS (itch) and SWELLING (swelling) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 26-Jan-2021, the patient experienced PRURITUS (itch) and SWELLING (swelling). At the time of the report, PAIN IN EXTREMITY (sore arm), PRURITUS (itch) and SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.    Reporter did not allow further contact
Redness and swelling over right deltoid area. Slight pain localized to deltoid area. Treat with warm compresses and observe for progression.
On 4/1/13, the patient stated her arm was red, swollen, & itchy.  Patient presented to the ER on 4/8/13 with same complaints. Area of inject site noted to be "softball sized."  Patient was given hydroxyzine and oral antibiotics, as the ER physician thought that it was an allergic reaction and/or cellulitis.
CRYING/SCREAMING EVERY 20-30 MIN, FALLING ON FLOOR IN PAIN, VOMITING.
Took the same Pfizer COVID shot also was down for 3 days with fever; Arm soreness and little stiffness; Arm soreness and little stiffness; Chills; little pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Took the same Pfizer COVID shot also was down for 3 days with fever"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE REACTION (non-serious), outcome "unknown" and all described as "Arm soreness and little stiffness"; CHILLS (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "little pain".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300340866 Same reporter and drug, similar events, different patient;
Patient experienced lightheadhedness, dizziness, nausea, syncope within the first 15 minutes of moderna administration. Patient left the observation area prior to the 15 minutes. Paramedics were called and evaluated patient. Determined patient was okay and needed no further medical attention and told patient to stay in the pharmacy waiting area for 15 more minutes for observation. patient left without further incidents.
first dose 2 years ago, recently received second; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose approximately 2 years ago).   In August 2022, the patient received the 2nd dose of Shingrix. In August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 29-Aug-2022 Reporter's comment: The patient just received the second dose. Did not consent to follow-up. Additional supportive information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule.
FOLLOWING DAY, DEVELOPED NAUSEA AND VOMITING THAT LASTED 7 HOURS BEFORE RESOLVING.
dizziness; nausea; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced DIZZINESS (dizziness), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills). The patient was treated with RIZATRIPTAN BENZOATE (MAXALT) at a dose of 1 dosage form; MECLOZINE HYDROCHLORIDE (ANTIVERT [MECLOZINE HYDROCHLORIDE]) at a dose of 1 dosage form; MECLIZINE [MECLOZINE] at a dose of 1 dosage form and BENZYL BENZOATE at a dose of 1 dosage form. At the time of the report, DIZZINESS (dizziness), NAUSEA (nausea), HEADACHE (headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Reporter declined consent for further follow up
W/in 24hrs p/recvd vax pt devel low grade fever & irritability & swelling @ inject site; Pt subsequently recovered; No further details were provided;
The vaccine was diluted with sterile diluent instead of the (blue cap) ActHib part of the Pentacel Kit.
Pt describes lingering pain at the injection site and painful movement of shoulder with limited range of motion continuing for 10 days post injection. Pt will be following up with Dr. on 11-15-2023 to assess the shoulder.
Cold Symptoms and some diarrhea from Paxlovid and Z pack.  Doctor proscribed Benzonatate, Dexamethasone, Paxlovid, and a Z-pak.  Symptoms are getting a little better but not recovered at time of reporting.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vial was refrigerated on 07-May-2021.  No concomitant medication was reported. No treatment information was reported.   This case was linked to MOD-2021-363032 (Patient Link).
Severe unusual headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe unusual headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Severe unusual headache). At the time of the report, HEADACHE (Severe unusual headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  Treatment details not reported.
Had COVID vaccine on January 9 . The next two days had chills  at night.  On  January 11 Daughter COVID test came back positive-she was not having symptoms was getting  tested for possible return to school. On January 13th  husband's test results came back positive for  COVID he had not symptoms.  I had not symptoms of COVID before COVID vaccine.   Between the second day until todays date did not record my symptoms (dates/times) but  I did have loss of appetite, diarrhea, loss of smell, tried to eat but nothing tasted good drank water ginger ale,  fevers between 103.7 (This was the highest recorded) to -102 for at least 5 days I took coated Tylenol 500 mg to decrease my fevers. Never had a cough or shortness of breath.  When performed house hold activities : for example moping floor would have to rest/sit down and take a break(felt tired/weak). Yesterday was the first time my temperature got below 100 degrees at 99.1 . Was able to eat a little solid food yesterday. Appetite better today.
Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/  expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/  expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/  expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/  expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  The vial did not undergo any temperature excursions. It was unknown when the vial was stored in refrigerator.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up document contains no additional information.
This spontaneous report was received from a registered nurse refers to an unspecified amount of patients of unknown age and gender. Nurse stated that on an unknown date in 2014 within the past 2 weeks an unspecified amount of patients were vaccinated with a dose of ROTATEQ oral route which was improperly stored. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Fever to 105, difficult to arouse for feedings the evening of administration of 1st DTP/OPV; Seen in office 9JAN AM t101 & cooing, smiling;
loud screaming high pitched-starring afraid, inc temp;unable to communicate;no rxn to parents voice or simple command-started 2nd day p/vax & got worse;given APAP;applied cool wet compress removed every 10-20min;call ER & tx @ ER;
Narrative: COVID infection following COVID vaccine series 03/04 ,Pfizer, dose #1 03/29, Pfizer, dose #2 08/11 COVID swab, result: detected 08/11 pt cc: dyspnea, chills, cough, diarrhea ,fatigue exposure: unknown 08/11 LDH result 381 08/11 HBSAG result: nonreactive 08/11 CRP 5.885 08/11 CXR impression: Patchy bilateral airspace opacities concerning for pneumonia.. 08/12 ABG i-pH 7.44, i-PCO2 30.4, i-PO2 67 , i-HCO3 20.6 08/13 - 08/21 Pt symptoms continue 08/12 pt admit to ED dx: covid pneumonia with hypoxia LOS: 2 days 08/12 FIBRINOGEN result: 658 08/12 DDIMER result: 0.33 08/13 ESR result: 94 08/14 FIBRINOGEN result: 469 08/14 DDIMER result: 0.26 08/14 ESR result: 80