chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Difficulty in swallowing; Breathing issue; Dizziness; Weakness; Sleepless nights; Excruciating pain; Night sweat; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Difficulty in swallowing), DYSPNOEA (Breathing issue), DIZZINESS (Dizziness), ASTHENIA (Weakness) and INSOMNIA (Sleepless nights) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Apr-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 DYSPHAGIA (Difficulty in swallowing), DYSPNOEA (Breathing issue), DIZZINESS (Dizziness), ASTHENIA (Weakness), INSOMNIA (Sleepless nights), PAIN (Excruciating pain), NIGHT SWEATS (Night sweat) and NAUSEA (nausea). At the time of the report, DYSPHAGIA (Difficulty in swallowing), DYSPNOEA (Breathing issue), DIZZINESS (Dizziness), ASTHENIA (Weakness), INSOMNIA (Sleepless nights), PAIN (Excruciating pain), NIGHT SWEATS (Night sweat) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
For the first dose, I broke out into a rash & had some shortness of breath (I forgot to mention that I have mild asthma.) The staff on site gave me Benadryl and observed me for 30 minutes. They said it was a mild, immediate reaction, but that it would be safe to receive my second shot. For the second dose, I had shortness of breath, broke out in a rash, had a fever of 101.3, had nausea, vomiting, dizziness, deep fatigue, weakness, exacerbation of joint pain, clamminess, muscle pain, severe headache, etc. I was sick for 7 weeks post vaccination. My rheumatologist- who had encouraged me to be vaccinated because of my being immunocompromised- prescribed a two-three week course of steroids because he told me that about 60% of his female patients who received the vaccine were ill like I was. He said if the steroids didn?t work, he would consider further treatment/hospitalization. The steroids helped with some of the most acute symptoms. One of my other physicians prescribed antibiotics, a powdered inhalation disc to help improve my breathing, and Tramadol for all of my aches and pains. We?re not certain that I have permanent issues as a result of the vaccinations, but I haven?t felt ?quite right? since.
I began to feel numbness on the lower left side of my face/I also had some numbness in general on the left side of my body; Hypersensitivity; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (I began to feel numbness on the lower left side of my face/I also had some numbness in general on the left side of my body) and HYPERSENSITIVITY (Hypersensitivity) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Hay fever, Allergy (itchy mouth) since 01-Jan-1970, Asthma since 06-Nov-1988, Hyperthyroidism since 01-Jan-1992, Allergy (itchy eyes, runny nose, scratchy throat) since 01-Jan-1982, Drug allergy (Seldane medication) since 05-Nov-1998, Allergy (stomach ache) since 01-Jan-1970 and Pre-diabetes since 01-Jan-2015. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) from 15-Nov-2020 to an unknown date for Asthma, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) from 01-Jan-2017 to an unknown date for Hyperthyroidism.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced HYPOAESTHESIA (I began to feel numbness on the lower left side of my face/I also had some numbness in general on the left side of my body) and HYPERSENSITIVITY (Hypersensitivity). The patient was treated with CETIRIZINE (oral) from 03-May-2021 to 08-May-2021 for Allergy, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) (oral) from 04-May-2021 to 07-May-2021 for Allergy, at an unspecified dose and frequency. On 12-May-2021, HYPERSENSITIVITY (Hypersensitivity) had resolved. At the time of the report, HYPOAESTHESIA (I began to feel numbness on the lower left side of my face/I also had some numbness in general on the left side of my body) had resolved. Not Provided          No treatment drugs were provided.   This case was linked to MOD-2021-103533 (Patient Link).
went into shock after she got it; This is a spontaneous report from a contactable consumer (daughter's friend) A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on unknown date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that "a friend of her daughter's went into shock after she got it" on an unspecified date with outcome of unknown.   Information on the lot/ batch number has been requested.
approximately 10 minutes after vaccine patient had shortness of breath and felt wheezy.  She also had intermittent itching and chills.  Rapid Response team notified and she was observed for an additional 30 minutes with improvement in symptoms. She was dismissed at 1000 to home
Angioedema of mouth, hives, nausea and vomiting concerning for anaphylaxis
Patient received his flu shot around 9:15am on Friday Oct 5th. He did well with the injection and went to school for the day. At pick up, around 5:30pm, he was noted to be feeling unwell. He was febrile upon temperature check at home by 6:00pm to 101.3F.  His fever persisted through Saturday afternoon Oct 6th with minimal other symptoms. Upon waking up on Sunday morning, Oct 7th, he had a prominent red rash (erythematous confluent maculopapular rash) over his face with some periorbital swelling and involvement of cheeks and ears bilaterally. He also had a rash over the dorsal and palmar sides of both hands. He received loratadine and BENADRYL with some improvement but the rash persisted all day into Monday Oct 8th. By Monday, he had a noticeable rash on his legs/feet as well. His torso and back were much less affected. No oral lesions or hand/foot lesions were noted.
Enlarge reaction-localized 2 1/2 x 2 1/2" Rx supportive/ warm compresses/BENADRYL 4/14/10.
pt recv vax 22JUL98 & mom called 23JUL in AM reports child awoke w/whelps & itching;instructed mom to give DPH & got to MD;mom reported dx allerg rxn to unk poss shots;
Stiffness in joints, legs and hands; Tingling in hands; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Stiffness in joints, legs and hands), PARAESTHESIA (Tingling in hands) and NAUSEA (Nausea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 047576) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since 06-Jun-1975, Lupus erythematosus (IV REMISSION Skin Lupus) since 07-Feb-1989, Drug allergy and Drug allergy (Codeine). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) from 10-Jul-1991 to an unknown date for Asthma, ESCITALOPRAM OXALATE (LEXAPRO) for Depression, MELATONIN from 20-Jan-2020 to an unknown date for Sleeplessness, LEVOTHYROXINE from 08-Mar-1980 to an unknown date for Thyroid disorder.   On 17-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT STIFFNESS (Stiffness in joints, legs and hands), PARAESTHESIA (Tingling in hands) and NAUSEA (Nausea). At the time of the report, JOINT STIFFNESS (Stiffness in joints, legs and hands) had not resolved and PARAESTHESIA (Tingling in hands) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were reported as Senna. The treatment information was unknown.   This case was linked to MOD-2021-281225 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant followup appended, Suspect details for second dose updated. On 09-Aug-2021: Follow up received and contain non significant information
On an unspecified date, the pt rec'd her 1st injection of Engerix-B. An unspecified time post immunization, the pt experienced a hypersensitivity reaction (NOS). Treatment and outcome were not specified.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: F59943) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  Clinical Course: The patient received Paxlovid anti-viral treatment for COVID-19 which was started on 14Jul2022 and treatment was ended on 18Jul2022. Paxlovid rebound. COVID symptoms started again on day 9 after completing Paxlovid treatment on days 1-5. The patient had adverse event with Paxlovid on 23Jul2022. The privacy policy consent was given. The device timestamp was 26Jul2022.   No follow-up attempts are needed. No further information is expected.
2 year old female, got MMR, varicella vaccine, Hib, PCV on 8/21/03. One week later developed generalized maculo papular-vesicular rash (varicella like) and fever; tx Benadryl and observation.
Awful headaches; Nausea; Chills; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Awful headaches), NAUSEA (Nausea), CHILLS (Chills) and FATIGUE (Extremely tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (Awful headaches), NAUSEA (Nausea), CHILLS (Chills) and FATIGUE (Extremely tired). At the time of the report, HEADACHE (Awful headaches), NAUSEA (Nausea), CHILLS (Chills) and FATIGUE (Extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
1-2 days after receiving vaccines, baby developed fine papular-macular rash on face. Baby afebrile and fine otherwise.
Information has been received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L034370, expiration date 08-SEP-2017; dose was unknown) via intramuscular injection. No adverse effects were reported. No product quality complaint (PQC) was involved. The excursion temperature was 29 Fahrenheit degree for 6 hours. There was no previous temperature excursion. No data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
On October 27th 2022nd A four-year-old patient received an unauthorized COVID Bivalent booster vaccine. When the parent made the vaccine appt for the Bivalent Booster, the. parent-reported (DOB) which would be the correct age for the bivalent booster dose Requested. Upon arrival, the client confirmed the incorrect DOB to the onsite registration staff and the Vaccinator giving the vaccine. This resulted in an invalid dose being administered. Currently, Bivalent. Boosters are not authorized for children less than 5 years.
Injection site be sore; very sore and sensitive; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a few months ago, refer case US2020AMR041766).   On 3rd March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site discomfort. On an unknown date, the outcome of the injection site pain and injection site discomfort were unknown.   It was unknown if the reporter considered the injection site pain and injection site discomfort to be related to Shingrix.  Additional deatils were provided as follows: The age at vaccination was not reported. The reporter asked how long should injection site be sore. The patient sttaed that, was concerned because it was vert sore and sensitive. For the tolerence of 1st  dose refer case US2020AMR041766, reported by same reporter for the same patient
This spontaneous report as received from a medical assistant refers to a 3 year old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 03-OCT-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37°F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868: Original Case: 1809USA002868; US-009507513-1902USA009324: Original Case: 1902USA009323; US-009507513-1902USA009325: Original Case: 1902USA009323; US-009507513-1902USA009326: Original Case: 1902USA009323.
expired beyond their storage and handling recommendation; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 16Sep2021 (Batch/Lot number: unknown, Expiration Date: Aug2021) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset Sep2021, outcome "unknown", described as "expired beyond their storage and handling recommendation".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed severe and constant pain in my jaw on the right side of my face. Pain continues to get worse. Went to the doctor on 5/17/22 for help and discussed a couple similar cases written about online calling it trigeminal neuralgia. The doctor has put me on Methylprednisolone for treatment and I am taking a large amount of ibuprofen just to dull the pain a little.
Information has been received from a physician concerning a 20 year old male with a history of a transplant X 2, as an infant and on 05-JUN-2002, and no allergies who on 04-MAY-2007 was vaccinated with a first 0.5ml subcutaneous dose of VARIVAX.  There was no concomitant medication.  On 04-MAY-2007, after being vaccinated with VARIVAX, the patient developed 15 small vesiculopapular lesions and a sore throat.  The physician examined the patient on 23-MAY-2007 and some of the lesions had scabs and the patient looked well.  At the time of this report, the patient was recovering.  The patient did not have varicella titers prior to vaccination.  No further information was available.  No product quality complaint was involved.  Additional information has been requested.
No additional AE/PQC reported at this time; HCP called in to report a temperature excursion. Caller reported MMR II had been administered to two patients; This spontaneous report was received from an office manager/physician and refers to a 12-month-old patient of unknown gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 19-JUL-2021, the patient was vaccinated with improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dosage regimen was not reported), lot # T001211 rHA and expiration date 12-JAN-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion above 46 degree fahrenheit (°F) (47.5) for 6 minutes on an unknown date; previous temperature excursions were the following: 46.8°F for 3 minutes and 47.8 for 5 minutes.  No adverse symptoms were reported.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-2107USA007018:
headache; chills; muscle & joint pain; muscle & joint pain; some GI Symptoms (nausea and diarrhea); some GI Symptoms (nausea and diarrhea); injections site soreness; This is a spontaneous report from a contactable pharmacist reported for self. This 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. She experienced injections site soreness on the day 07Jan2021 then resolved. The next day (08Jan2021) experienced headache, chills, muscle & joint pain, and some GI Symptoms (nausea and diarrhea). Outcome of the event injections site soreness was recovered. Outcome of other events was unknown.  Information on batch/lot number was requested.
At 5:00pm, 7.5hours after vaccination, began feeling fatigued, headache, muscle soreness. Fever by 8:00pm and more intense all over muscle pain and chills. Couldn?t get comfortable to sleep that night. Fever broke by 7:00am the next morning. Felt tired and sore muscles the whole day following vaccination.
body aches; Severe Arm Pain; could not lift her arm; Could not shower for 2 days; Could not eat for 2 days; caused a flare up of auto immune disease; Still not feeling normal; severe headaches; A spontaneous report was received from a consumer concerning a 58-female patient, who received Moderna COVID-19 vaccine (mRNA-1273) and experienced severe headache , body aches, severe arm pain so that she could not lift her arm and it caused a flare up of auto immune disease and could not shower or eat for 2 days. The patient's medical history was not provided. Relevant concomitant medications include Dupixent and Prednisone was reported. On 12-jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(lot number : 039K20A) intramuscularly on left upper arm  for the prophylaxis of COVID-19 infection. On 13-jan-2021, the patient experienced severe headache , body aches, severe arm pain so that she could not lift her arm and it caused a flare up of auto immune disease and could not shower or eat for 2 days. No treatment information was provided . Action taken with mRNA-1273 in response to the events was not reported. At the time of report, the outcome of the events severe headache , body aches, severe arm pain so that she could not lift her arm and it caused a flare up of auto immune disease and could not shower or eat for 2 days was unknown.
415PM mom phone to say pt leg was swollen from hip to ankle very red, has little fever & crying in pain;mom bought pt to clinic;lt leg is sl swollen, sl red & painful to touch @ site;MD examined child;vomiting, abd cramps;elevated temp;
Called 11/16/18 and complains that injecion given 11/11/18 after next day around 10 am felt muscle aches all over body (11/12/18) and also pins and needles. I adviced her to seek medical help immediately and will report this on VAERS, she has no fever.
Patient started  breaking out with minor rash on May 21 on our way to vacation four days after her Covid Shot.   Her mother and I thought it may be the sheets she slept on in the motel or maybe something she ate.  She was treated with Bendryl pill and cream.  the next few days at or destination  the rash got worse and worse itching was incredible and a bad headache.  On Tuesday evening Patient started swelling on her feet and hands her feet were somewhat blue   We got extremely concerned and called our Health Care Provider nurse Line.  With everything we provided to her relating to Patients symptoms she felt like calling 911 immediately would  e  best for her.  The place we were staying  is  very small and the hospital was 2 miles away my daughter just took her.   The attending physician treated her for a severe case of hives   She said that it was due to an unknown origin.  Patient just received her 2nd Pfizer Covid shot on June 7 and on June 8 started breaking out  with hives  we now know the shot was the culprit.  Hope this is helpful information
emesis; sweats; horrible headache; Extremely tired; chills; This is a spontaneous report from a contactable other health professional. A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EL0142) via an unspecified route of administration at left arm on 10Jan2021 at a single dose (dose number: 2) for COVID-19 immunization. Medical history included allergies to cefaclor (CECLOR), azithromycin (ZITHROMAX Z-PACK, reported as z pack), pinapple, coconut. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included warfarin sodium (JANTOVEN), sertiline, metformin (reported as metforman, to be clarified). Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: EK5730) intramuscularly at left arm on 20Dec2020 at 09:30 AM at a single dose (dose number: 1) for COVID-19 immunization and reported events included emesis within 40 minutes, upset stomach for 3 hours approx, sweating and headache, lasting about 4 hours. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient was not pregnant at the time of vaccination. After the 2nd shot, it was reported emesis within 40 minutes and lasting all day, extremely tired, horrible headache, sweats and chills. This lasted 36 hours. Start date of adverse event was reported as 10Jan2021 at 10:30 AM. No treatment received for the adverse events. The outcome of events was resolved in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.